Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 39
- Latest Decision
- 2026-02-06
Clearances · page 2 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | KCT | Class II | 2026-02-06 |
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | SCL | Class II | 2026-01-30 |
| K251354 | UV Smart D60 | UV Smart Technologies B.V. | SCS | Class II | 2026-01-29 |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | FRG | Class II | 2026-01-28 |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | FRN | Class II | 2026-01-28 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | LZA | Class I | 2026-01-23 |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | FLE | Class II | 2026-01-22 |
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) | Thera B Medical Products | LBI | Class II | 2026-01-15 |
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | LZC | Class I | 2026-01-14 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | LZA | Class I | 2026-01-13 |
| K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | KPE | Class II | 2026-01-09 |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | FLL | Class II | 2026-01-08 |
| K252886 | Pen Needle | Hh Global Technology, Inc. | FMI | Class II | 2026-01-06 |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | FLE | Class II | 2025-12-30 |
| DEN250004 | QIKCAP System | Hai Solutions | SGX | Class II | 2025-12-23 |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | JOJ | Class II | 2025-12-23 |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | MMK | Class II | 2025-12-22 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | FMF | Class II | 2025-12-22 |
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | PKP | Class II | 2025-12-22 |
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | PND | Class II | 2025-12-18 |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | FOZ | Class II | 2025-12-17 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | FMF | Class II | 2025-12-17 |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology | Spectrum Vascular | LJS | Class II | 2025-12-16 |
| K250847 | VaporShield | Vault Paragon Group, Inc. | MEG | Class II | 2025-12-12 |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | FRG | Class II | 2025-12-12 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | FMF | Class II | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | FMF | Class II | 2025-12-10 |
| K251722 | ProSeal Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | ONB | Class II | 2025-12-05 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | FPA | Class II | 2025-12-04 |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Becton, Dickinson and Company | NGT | Class II | 2025-12-02 |
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | Sb-Kawasumi Laboratories, Inc. | PTI | Class II | 2025-11-26 |
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | QLY | Class II | 2025-11-21 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | FMI | Class II | 2025-11-21 |
| K252636 | Fluido Compact System | The Surgical Company International B.V. | LGZ | Class II | 2025-11-18 |
| K252792 | PM2 System with ECGuide Connector | Piccolo Medical, Inc. | LJS | Class II | 2025-11-17 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | LZA | Class I | 2025-11-17 |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | KCT | Class II | 2025-11-14 |
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited | FRF | Class II | 2025-11-14 |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | FOZ | Class II | 2025-11-05 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | 2025-11-04 |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | FRG | Class II | 2025-10-31 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | FPA | Class II | 2025-10-30 |
| K252467 | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd. | LYZ | Class I | 2025-10-27 |
| K250345 | Medline Bag Decanter | Medline Industries, LP | LHI | Class II | 2025-10-24 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2025-10-23 |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | FMZ | Class II | 2025-10-22 |
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | ONB | Class II | 2025-10-21 |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | LZA | Class I | 2025-10-17 |
| K252631 | Profoject Disposable Needle | CMT Health PTE., Ltd. | FMI | Class II | 2025-10-16 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | FMF | Class II | 2025-10-15 |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | LHI | Class II | 2025-10-14 |
| K252637 | Community Containers (Flap and Daisy) | Keter Canada, Inc. | MMK | Class II | 2025-10-14 |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | MMK | Class II | 2025-10-14 |
| K243815 | SoClean 3+ | Soclean, Inc. | QXQ | Class II | 2025-10-10 |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2025-10-08 |
| K252680 | Celerity 20 HP Biological Indicator | STERIS Corporation | FRC | Class II | 2025-09-24 |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | LHI | Class II | 2025-09-16 |
| K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | FRA | Class II | 2025-09-15 |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Becton, Dickinson and Company | ONB | Class II | 2025-09-12 |
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Bard Access Systems, Inc. | LJT | Class II | 2025-09-05 |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | LGZ | Class II | 2025-09-04 |
| K251814 | EZ IV Administration Set | Epic Medical Pte. , Ltd. | FPA | Class II | 2025-08-29 |
| K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | LYZ | Class I | 2025-08-28 |
| K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | QOG | Class II | 2025-08-28 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | LZA | Class I | 2025-08-27 |
| K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | FMF | Class II | 2025-08-22 |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | 2025-08-21 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | 2025-08-18 |
| K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | FMZ | Class II | 2025-08-14 |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | FLE | Class II | 2025-08-14 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | FPA | Class II | 2025-08-06 |
| K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. | ONB | Class II | 2025-08-05 |
| K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene | FRC | Class II | 2025-08-04 |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Access Vascular, Inc. | LJS | Class II | 2025-08-01 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | FPA | Class II | 2025-08-01 |
| K252094 | eZSURE Empty Fluid Container | Epic Medical Pte. , Ltd. | KPE | Class II | 2025-08-01 |
| K250127 | TSK Syringe | Tsk Laboratory, Japan | QNQ | Class II | 2025-07-30 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | FMI | Class II | 2025-07-30 |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2025-07-30 |
| K251350 | BD Plastipak Syringe | Becton, Dickinson and Company | FMF | Class II | 2025-07-29 |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) | Baxter Healthcare Corporation | FRN | Class II | 2025-07-28 |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | FRN | Class II | 2025-07-28 |
| K243403 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2025-07-25 |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | CMT Health PTE., Ltd. | FMF | Class II | 2025-07-25 |
| K250284 | TSK SELECT Needle | Tsk Laboratory, Japan | FMI | Class II | 2025-07-24 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | FPA | Class II | 2025-07-24 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | KCT | Class II | 2025-07-22 |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | KCT | Class II | 2025-07-22 |
| K243404 | HyHub and HyHub Duo Vial Access Devices | Takeda Pharmaceuticals | LHI | Class II | 2025-07-18 |
| K251482 | AEON Endoscopic Powered Stapler | Lexington Medical, Inc. | GAG | Class II | 2025-07-11 |
| K251155 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2025-07-11 |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology, Inc. | LZA | Class I | 2025-07-09 |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | FMI | Class II | 2025-07-08 |
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Encompass Industries Sdn. Bhd. | LZA | Class I | 2025-07-08 |
| K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Zibo Shengkun Chemical Industry Co., Ltd. | LZA | Class I | 2025-07-07 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | FMF | Class II | 2025-07-03 |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. | LJS | Class II | 2025-07-01 |
| K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | OZW | Class II | 2025-06-30 |
| K251654 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2025-06-27 |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | FRG | Class II | 2025-06-26 |
15,723 clearances in the General Hospital panel. Data: openFDA.