Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 39
- Latest Decision
- 2025-01-15
Clearances · page 4 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K242936 | Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Sunray Medical Products, Inc. | LZA | Class I | 2025-01-15 |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2025-01-10 |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2025-01-08 |
| K242741 | ACE Cannula | Ace Medical Industry Co., Ltd. | FMI | Class II | 2025-01-08 |
| K240517 | ProSeal Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-12-26 |
| K242434 | Insulin Syringes | Chirana T. Injecta | FMF | Class II | 2024-12-24 |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | Belmont Medical Technologies | FRN | Class II | 2024-12-23 |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | FMF | Class II | 2024-12-23 |
| K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | FOZ | Class II | 2024-12-20 |
| K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | QLY | Class II | 2024-12-20 |
| K243128 | Klockner Kits | SOADCO, S.L. | KCT | Class II | 2024-12-18 |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | FPA | Class II | 2024-12-18 |
| K241036 | Autoclave Indicator Tape; EO Indicator Tape | Jiangmen New Era External Use Drug Co., Ltd. | JOJ | Class II | 2024-12-17 |
| K242558 | Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | 2024-12-17 |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | Terragene S.A. | FRC | Class II | 2024-12-12 |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | LHI | Class II | 2024-12-06 |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | JOJ | Class II | 2024-12-04 |
| K243232 | GripMate | Synthon Hispania S.L. | KZH | Class II | 2024-12-02 |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | Bard Access Systems, Inc. | PTI | Class II | 2024-11-27 |
| K243354 | Remunity System | Deka Research & Development Corp. | QJY | Class II | 2024-11-27 |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | Spectrum Vascular | FOZ | Class II | 2024-11-27 |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | FRC | Class II | 2024-11-25 |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle | Sol-Millennium Medical, Inc. | QNQ | Class II | 2024-11-20 |
| K242102 | CerroZone Mini | Cerrozone, LLC | FRF | Class II | 2024-11-19 |
| K243273 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | OPP | Class II | 2024-11-13 |
| DEN230085 | VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator | Steris | SDC | Class II | 2024-11-12 |
| K240624 | InfuLife | First Medical Source, LLC | MEB | Class II | 2024-11-05 |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever | FRG | Class II | 2024-11-04 |
| K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) | GAG | Class II | 2024-11-01 |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Bard Access Systems, Inc. | LJT | Class II | 2024-10-31 |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | FLL | Class II | 2024-10-30 |
| K240269 | Nitrile Powder Free Examination Gloves Biodegradable (Green) | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2024-10-25 |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | FLL | Class II | 2024-10-25 |
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | Ocuject, LLC | QNS | Class II | 2024-10-25 |
| K241988 | ProSeal Closed System Bag Access | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-10-23 |
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Tsk Laboratory International Japan KK | QYM | Class II | 2024-10-23 |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | FMF | Class II | 2024-10-22 |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company | FRC | Class II | 2024-10-18 |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | FRG | Class II | 2024-10-16 |
| K242795 | Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) | JOJ | Class II | 2024-10-15 |
| K242812 | NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) | Nb Medical Company Limited | LZA | Class I | 2024-10-12 |
| K241735 | ProSeal In Line Pump Set (423850) | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-10-10 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | FRG | Class II | 2024-10-07 |
| K242693 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development Corporation | LDR | Class II | 2024-10-07 |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | MEB | Class II | 2024-10-07 |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. | FRN | Class II | 2024-10-03 |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation | JOJ | Class II | 2024-09-30 |
| K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | 2024-09-27 |
| K241916 | TearRepair Liquid Skin Protectant | Optmed, Inc. | KMF | Class I | 2024-09-27 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | FLL | Class II | 2024-09-27 |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2024-09-26 |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. | FMF | Class II | 2024-09-20 |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | FPA | Class II | 2024-09-20 |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. | FRC | Class II | 2024-09-18 |
| K241123 | Perpak Sterilization Tyvek Pouch | Km Corp. | FRG | Class II | 2024-09-18 |
| K231893 | LOWTEM Crystal 120 | Lowtem Co., Ltd. | MLR | Class II | 2024-09-18 |
| K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | FRG | Class II | 2024-09-17 |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap | O&M Halyard, Inc. | FRG | Class II | 2024-09-16 |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | FRC | Class II | 2024-09-12 |
| K241745 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) | Ksg Medicare Sdn. Bhd. | LZA | Class I | 2024-09-11 |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | LYY | Class I | 2024-09-09 |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | LJS | Class II | 2024-09-08 |
| K241415 | Orchid Safety Release Valve | Linear Health Sciences, LLC | QOI | Class II | 2024-09-06 |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | LHI | Class II | 2024-09-06 |
| K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | FRN | Class II | 2024-09-05 |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | LZG | Class II | 2024-09-04 |
| K231095 | Tamper Evident Cap | International Medical Industries, Inc. | FMF | Class II | 2024-09-04 |
| K241823 | ToxiSeal Vial Adaptor | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-08-30 |
| DEN230067 | Chronos® | Germitec | SCS | Class II | 2024-08-28 |
| K240545 | GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) | Genabio Diagnostics, Inc. | LZA | Class I | 2024-08-28 |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | KCT | Class II | 2024-08-23 |
| K241780 | Cardinal Health Nitrile Exam Gloves | Cardinal Health200, LLC | LZA | Class I | 2024-08-23 |
| K242126 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | FPA | Class II | 2024-08-22 |
| K241803 | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | QOG | Class II | 2024-08-22 |
| K242189 | CELERITY HP Indicator Tape (PCC077) | Steris | JOJ | Class II | 2024-08-20 |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | FLL | Class II | 2024-08-20 |
| K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | FMF | Class II | 2024-08-15 |
| DEN210037 | SoClean 3+ Bacterial Reduction Device | Soclean, Inc. | QXQ | Class II | 2024-08-12 |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. | FRG | Class II | 2024-08-07 |
| K241528 | Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | Comfort Rubber Gloves Industries Sdn. Bhd. | LZA | Class I | 2024-08-06 |
| K241970 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | 2024-08-02 |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | FRA | Class II | 2024-08-01 |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | KCT | Class II | 2024-07-31 |
| K240359 | PowerGlide Pro Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | FOZ | Class II | 2024-07-29 |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2024-07-26 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | LHI | Class II | 2024-07-26 |
| K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | KCT | Class II | 2024-07-16 |
| K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | QEH | Class II | 2024-07-13 |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | Terragene S.A. | QVB | Class II | 2024-07-12 |
| K241378 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | KCT | Class II | 2024-07-12 |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | FMF | Class II | 2024-07-10 |
| K234084 | STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count) | Advanced Sterilization Products, Inc. | JOJ | Class II | 2024-07-05 |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104); APTIMAX Instrument Tray for ULTRA GI Cycle (011077) | Advanced Sterilization Products | MLR | Class II | 2024-07-05 |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) | Ethicon Endo-Surgery, LLC | GAG | Class II | 2024-07-03 |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | LZG | Class II | 2024-07-02 |
| K240930 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue | Sri Trang Gloves Thailand (Public Company Limited) | LZA | Class I | 2024-07-02 |
| K240915 | ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. | FMI | Class II | 2024-07-02 |
| K233762 | SteroScope® Sterilization Technology System | Ideate Medical, Inc. | MLR | Class II | 2024-06-27 |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | 3M Company | FRC | Class II | 2024-06-27 |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | FRC | Class II | 2024-06-27 |
15,723 clearances in the General Hospital panel. Data: openFDA.