Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 39
- Latest Decision
- 2024-06-26
Clearances · page 5 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | LHI | Class II | 2024-06-26 |
| K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | JOJ | Class II | 2024-06-26 |
| K233368 | Allograft Delivery Device (OFAC-C) | Bioventus, LLC | FMF | Class II | 2024-06-25 |
| K240824 | Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) | Ningxia Qiaoen Medical Technology Co., Ltd. | LZA | Class I | 2024-06-25 |
| K233280 | SteadyTemp | Steadysense GmbH | FLL | Class II | 2024-06-21 |
| K241476 | ToxiSeal Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-06-21 |
| K233096 | PRESSUREALERT® Pressure Monitoring System | Position Health, LLC | SBO | Class I | 2024-06-21 |
| K240862 | Medicom Sterilization Wrap | Medicom Group, Inc. | FRG | Class II | 2024-06-21 |
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site | Epic Medical Pte. , Ltd. | KPE | Class II | 2024-06-21 |
| K240774 | Pen Injector | Wuxi Nest Biotechnology Co., Ltd. | FMF | Class II | 2024-06-18 |
| K240696 | Airdog X8 Air Purifier (KJ800F-X8) | Suzhou Beiang Smart Technology Co., Ltd. | FRF | Class II | 2024-06-14 |
| K240256 | Remunity System | Deka Research and Development | QJY | Class II | 2024-06-12 |
| K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle | Perfect Medical Industry (Vn) Co., Ltd. | FMF | Class II | 2024-06-12 |
| K240910 | EO Chex Indicator Tape | Propper Manufacturing Co., Inc. | JOJ | Class II | 2024-06-12 |
| K241344 | MetriCide OPA Plus Solution Test Strip | Steris | JOJ | Class II | 2024-06-11 |
| K232625 | Steriking® Pouch for Robotic Instruments | Wipak OY | FRG | Class II | 2024-06-07 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | FLL | Class II | 2024-06-05 |
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corporation | KCT | Class II | 2024-06-03 |
| K232107 | °M Warmer System | Mequ A/S | LGZ | Class II | 2024-05-31 |
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | QNQ | Class II | 2024-05-31 |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | QNQ | Class II | 2024-05-29 |
| K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Xingyu Medical Tech Co., Ltd. | LZA | Class I | 2024-05-28 |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | Primed Medical Products, Inc. | FRG | Class II | 2024-05-24 |
| K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | FRA | Class II | 2024-05-23 |
| K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-05-21 |
| DEN230068 | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 | 3M Company | SBE | Class II | 2024-05-21 |
| K241252 | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | LYZ | Class I | 2024-05-20 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | Zevex, Inc. | FRN | Class II | 2024-05-17 |
| K232933 | AirKEE P900 | Healkee Medical Pte, Ltd. | FRA | Class II | 2024-05-16 |
| K232614 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | Sri Trang Gloves (Thailand) Public Company Limited | LZA | Class I | 2024-05-13 |
| K233277 | Filter Needle for Single Use | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | FPB | Class II | 2024-05-10 |
| K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | FPA | Class II | 2024-05-10 |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | Lexington Medical, Inc. | GAG | Class II | 2024-05-07 |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | LHI | Class II | 2024-05-03 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | LHI | Class II | 2024-05-01 |
| K232319 | Black Pearl Nitrile Examination Glove | Ug Global Resources Sdn. Bhd. | LZA | Class I | 2024-04-22 |
| K233106 | AccuCath Ace Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | FOZ | Class II | 2024-04-19 |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | JOJ | Class II | 2024-04-17 |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | LHI | Class II | 2024-04-16 |
| K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | FPA | Class II | 2024-04-12 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | FLL | Class II | 2024-04-12 |
| K240760 | CELERITY HP Indicator Tape | Steris | JOJ | Class II | 2024-04-10 |
| K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Yue Kang Anhui Medical Products Co., Ltd. | LZA | Class I | 2024-04-08 |
| K223914 | ACTIV Cap | Cleansite Medical, Inc. | QBP | Class II | 2024-04-05 |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. | QKM | Class II | 2024-04-05 |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited | FLL | Class II | 2024-04-05 |
| K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | LZA | Class I | 2024-04-04 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | FLE | Class II | 2024-04-04 |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd | FLL | Class II | 2024-04-03 |
| DEN230036 | Sepsis ImmunoScore | Prenosis, Inc. | SAK | Class II | 2024-04-02 |
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Syntex Healthcare Products Co., Ltd. | LZA | Class I | 2024-04-02 |
| K233990 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Shandong Xingyu Gloves Co., Ltd. | LZA | Class I | 2024-04-01 |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | PHC | Class II | 2024-03-29 |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation | FRN | Class II | 2024-03-29 |
| K240171 | ProSeal Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-03-28 |
| K234097 | Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Ever Growth (Vietnam) Corporation Limited | LZA | Class I | 2024-03-27 |
| K233069 | Removal System Large Bore 60 cc Syringe | Inari Medical, Inc. | PUR | Class II | 2024-03-26 |
| K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | O&M Halyard, Inc. | LZA | Class I | 2024-03-22 |
| K233262 | Dukal SMS Sterilization Wrap | Dukal, LLC | FRG | Class II | 2024-03-22 |
| K233578 | BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC | KCT | Class II | 2024-03-22 |
| K232654 | Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | LZA | Class I | 2024-03-20 |
| K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMF | Class II | 2024-03-19 |
| K232234 | Nouvo Safety Set | Poly Medicure Limited | FOZ | Class II | 2024-03-15 |
| K233881 | ivWatch® Model 400 | Ivwatch, LLC | PMS | Class II | 2024-03-15 |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | 3M Company | FRC | Class II | 2024-03-15 |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) | Medexel Co.,Ltd | QNQ | Class II | 2024-03-15 |
| K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | Tsk Laboratory International Japan KK | QNS | Class II | 2024-03-08 |
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | Care Fusion | LHI | Class II | 2024-03-06 |
| K233794 | Insulin Syringe | Spm Medicare Pvt. , Ltd. | FMF | Class II | 2024-03-06 |
| K240023 | Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. | FLL | Class II | 2024-03-01 |
| K231365 | Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves | Anhui Intco Medical Products Co., Ltd. | LZA | Class I | 2024-03-01 |
| K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | LDR | Class II | 2024-03-01 |
| K232328 | Insignis Syringe Infusion System | Innovative Health Sciences, LLC | FPA | Class II | 2024-03-01 |
| K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | 2024-02-29 |
| K233623 | Praxiject SP 0.9% NaCl | Medxl, Inc. | NGT | Class II | 2024-02-27 |
| K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2024-02-26 |
| K232645 | Airgle Room Air Purifier | Airgle Corporation | FRA | Class II | 2024-02-16 |
| K240148 | SCIg60 Infusion System | Emed Technologies Corporation | PKP | Class II | 2024-02-16 |
| K230235 | Medline Luer Lock Syringes | Medline Industries, LP | FMF | Class II | 2024-02-16 |
| K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | W.A. Rubbermate Co., Ltd. | LZA | Class I | 2024-02-13 |
| K240072 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Luliang Hongruida Health Protection Technology Co., Ltd. | LZA | Class I | 2024-02-09 |
| K232473 | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | FLL | Class II | 2024-02-09 |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | FLE | Class II | 2024-02-08 |
| K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2024-02-07 |
| K231625 | VitalDetect | Wellvii, Inc. | FLL | Class II | 2024-02-02 |
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Berpu Medical Technology Co., Ltd. | FMI | Class II | 2024-02-01 |
| K232678 | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | FLL | Class II | 2024-01-31 |
| K233598 | Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | Anhui Intco Medical Products Co., Ltd. | LZA | Class I | 2024-01-26 |
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | LHI | Class II | 2024-01-19 |
| K233447 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | OPP | Class II | 2024-01-18 |
| K231144 | Washtrays | Dentsply Sirona | KCT | Class II | 2024-01-16 |
| K233970 | Nephron Nitrile, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | LZA | Class I | 2024-01-16 |
| K233520 | Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | Anhui Powerguard Technology Co., Ltd. | LZA | Class I | 2024-01-12 |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | QOG | Class II | 2024-01-12 |
| K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | FMF | Class II | 2024-01-12 |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | ONB | Class II | 2024-01-11 |
| K232250 | SurgiCount+ System | Stryker Instruments | PBZ | Class II | 2024-01-11 |
| K231707 | ResQ Administration Set | Q For Plastic Industries | FPA | Class II | 2024-01-03 |
| K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | LGM | Class II | 2024-01-03 |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2023-12-28 |
15,723 clearances in the General Hospital panel. Data: openFDA.