Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 36
- Latest Decision
- 2025-06-24
Clearances · page 3 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | FMF | Class II | 2025-06-24 |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | 2025-06-23 |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson | PHC | Class II | 2025-06-20 |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | KCT | Class II | 2025-06-20 |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | FLL | Class II | 2025-06-20 |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Bard Access Systems, Inc. | LJT | Class II | 2025-06-18 |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | O&M Halyard, Inc. | LZA | Class I | 2025-06-18 |
| K243133 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Kl-Kepong Rubber Products Sdn. Bhd. | LZA | Class I | 2025-06-17 |
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | QOG | Class II | 2025-06-09 |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | FRG | Class II | 2025-06-06 |
| K243694 | Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue | Mah Sing Healthcare Sdn. Bhd. | LZA | Class I | 2025-06-06 |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | FLE | Class II | 2025-06-06 |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Steris | FRC | Class II | 2025-06-06 |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | FPA | Class II | 2025-06-05 |
| K251035 | DISINTEK PA Test Strips | Serim Research | JOJ | Class II | 2025-06-03 |
| K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2025-06-03 |
| K243796 | GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Glove One, LLC | LZA | Class I | 2025-06-03 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | FMI | Class II | 2025-05-29 |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | LJS | Class II | 2025-05-29 |
| K243372 | BiliWrap | Gerium Medical, Ltd. | LBI | Class II | 2025-05-29 |
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | ONB | Class II | 2025-05-29 |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | Iradimed Corporation | FRN | Class II | 2025-05-28 |
| K242604 | Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | QXJ | Class II | 2025-05-27 |
| K250630 | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | LZA | Class I | 2025-05-22 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | FLL | Class II | 2025-05-22 |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | FOZ | Class II | 2025-05-16 |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | KCT | Class II | 2025-05-13 |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | PTI | Class II | 2025-05-13 |
| K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | QLY | Class II | 2025-05-09 |
| K242732 | Tristel OPH | Tristel Solutions , Ltd. | QWS | Class II | 2025-05-09 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | FPA | Class II | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | FPA | Class II | 2025-05-02 |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | FOZ | Class II | 2025-05-02 |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | JOJ | Class II | 2025-05-02 |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | KCT | Class II | 2025-05-01 |
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. | LYY | Class I | 2025-04-29 |
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | FMG | Class II | 2025-04-29 |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | FLL | Class II | 2025-04-25 |
| K243876 | VERIFY STEAM Integrating Indicator | STERIS Corporation | JOJ | Class II | 2025-04-25 |
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. | FRN | Class II | 2025-04-25 |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | FRG | Class II | 2025-04-25 |
| K250262 | GO-PEN® | Go-Pen Aps | FMF | Class II | 2025-04-24 |
| K250944 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl | Gmp Medicare Sdn. Bhd. | LZA | Class I | 2025-04-23 |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex Sas. | KPE | Class II | 2025-04-18 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | FMI | Class II | 2025-04-18 |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | MLR | Class II | 2025-04-14 |
| K242429 | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | Becton Dickinson Inc. (Bd) | SEF | Class II | 2025-04-09 |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. | QLY | Class II | 2025-04-08 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | FMI | Class II | 2025-04-04 |
| DEN240031 | Prapela SVS hospital bassinet pad (model P01) | Prapela, Inc. | QVY | Class II | 2025-04-04 |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | Turbett Surgical | FRG | Class II | 2025-04-04 |
| K250658 | SureFine Pen Needle | Shina Med Corporation | FMI | Class II | 2025-04-03 |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | QLY | Class II | 2025-04-03 |
| K242114 | Plum Solo Precision IV Pump | Icu Medical, Inc. | FRN | Class II | 2025-04-02 |
| K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | QNQ | Class II | 2025-04-02 |
| K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | PHC | Class II | 2025-04-02 |
| K242115 | Plum Duo Precision IV Pump | Icu Medical, Inc. | FRN | Class II | 2025-04-02 |
| K250578 | Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn. Bhd. | LZA | Class I | 2025-04-01 |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | KCT | Class II | 2025-03-28 |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | Access Vascular, Inc. | FOZ | Class II | 2025-03-27 |
| K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | QOG | Class II | 2025-03-27 |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Prismatik Dentalcraft, Inc. | KCT | Class II | 2025-03-21 |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | LHI | Class II | 2025-03-21 |
| DEN240018 | CORIS System | Nanosonics Limited | SEW | Class II | 2025-03-19 |
| K250502 | SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) | Safesource Direct, LLC | LZA | Class I | 2025-03-19 |
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2025-03-18 |
| K243599 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | FOZ | Class II | 2025-03-14 |
| K250401 | AION TempShield | Aion Biosystems, Inc. | FLL | Class II | 2025-03-14 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | FPA | Class II | 2025-03-14 |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | PTI | Class II | 2025-03-14 |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | FRN | Class II | 2025-03-11 |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. | GAG | Class II | 2025-03-10 |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | FLE | Class II | 2025-03-07 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | FPA | Class II | 2025-02-28 |
| K241587 | pilot TLS | Vygon Corporation | LJS | Class II | 2025-02-26 |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | LZC | Class I | 2025-02-24 |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | FRG | Class II | 2025-02-24 |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | FRG | Class II | 2025-02-21 |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | FRG | Class II | 2025-02-21 |
| K250172 | Green Card Bowie-Dick Test (BD115) | Steritec Products, Inc. (A Getinge Company) | JOJ | Class II | 2025-02-20 |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | KCT | Class II | 2025-02-19 |
| K243792 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) | Basic Medical Technology, Inc. | LZA | Class I | 2025-02-18 |
| K243503 | VIA360 Surgical System | New World Medical, Inc. | MRH | Class II | 2025-02-14 |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | FLL | Class II | 2025-02-14 |
| K243778 | Body Temperature Software (BTS) | Fitbit, LLC | QZA | Class II | 2025-02-13 |
| K243317 | NUVENTUS NV.C Surgical Cassette and Tray | Infinitum Eta, Ltd. | KCT | Class II | 2025-02-11 |
| K244034 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | 2025-02-06 |
| K250061 | Celerity Incubator | STERIS Corporation | FRC | Class II | 2025-02-06 |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | STERIS Corporation | FRC | Class II | 2025-02-06 |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | FMF | Class II | 2025-02-05 |
| K243441 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) | Basic Medical Technology, Inc. | LZA | Class I | 2025-01-31 |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | 3M Company | FRC | Class II | 2025-01-28 |
| K243985 | Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. | LHI | Class II | 2025-01-22 |
| K243976 | ZeroClear Bag Access (423100) | Epic Medical Pte. , Ltd. | ONB | Class II | 2025-01-22 |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | LJS | Class II | 2025-01-19 |
| K243606 | Babyroo TN300 | Draeger Medical Systems, Inc. | FMT | Class II | 2025-01-17 |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15) | True Indicating, LLC | JOJ | Class II | 2025-01-17 |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | Access Vascular, Inc. | LJS | Class II | 2025-01-17 |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | KCT | Class II | 2025-01-16 |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | FRN | Class II | 2025-01-16 |
15,723 clearances in the General Hospital panel. Data: openFDA.