Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 30
- Latest Decision
- 2019-01-31
Clearances · page 20 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 | STERIS Corporation | MED | Class II | 2019-01-31 |
| K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | LGZ | Class II | 2019-01-28 |
| K173743 | Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. | MEG | Class II | 2019-01-28 |
| K180767 | FEMON Banana Thermometer | Life Science Technology, Inc. | FLL | Class II | 2019-01-22 |
| K181106 | Powder Free Nitrile Patient Examination Gloves, Blue Color | Jiangsu Dongxin Medical Technology Co., Ltd. | LZA | Class I | 2019-01-16 |
| K182538 | Merit RadialFlo Arterial Catheter | Merit Medical Singapore Pte. , Ltd. | FOZ | Class II | 2019-01-16 |
| K182545 | Tamper Evident Cap with Male Luer Lock | International Medical Industries, Inc. | FPA | Class II | 2019-01-11 |
| K180355 | Advocate Non-Contact Infrared Thermometer | Broadmaster Biotech, Corp. | FLL | Class II | 2019-01-10 |
| K180387 | Infrared Ear Thermometer | Hetaida Technology Co., Ltd. | FLL | Class II | 2019-01-10 |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | LZG | Class II | 2019-01-08 |
| K183293 | VERIFY VH202 Indicator Tape | STERIS Corporation | JOJ | Class II | 2019-01-04 |
| K183295 | Celerity HP Chemical Indicator (CI) | Steris Corporations | JOJ | Class II | 2019-01-04 |
| K183297 | Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation | FRG | Class II | 2019-01-03 |
| K180983 | Maxcon Two Gallon Chemotherapy Container | Ningbo Maxcon Medical Technology Co., Ltd. | MMK | Class II | 2019-01-03 |
| K183300 | VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack | Steris Corporations | FRC | Class II | 2019-01-03 |
| K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | 2019-01-03 |
| K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | MMK | Class II | 2019-01-03 |
| K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation | FRC | Class II | 2019-01-03 |
| K180139 | Safe Secure Sterilization Pouches and Rolls | Safe Secure Packing Co., Ltd. | FRG | Class II | 2019-01-03 |
| K183301 | PRO-LITE Sterilization Tray | STERIS Corporation | KCT | Class II | 2019-01-03 |
| K181215 | Infrared Thermometer | Shenzhen Finicare Co., Ltd. | FLL | Class II | 2019-01-02 |
| K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | FRC | Class II | 2018-12-27 |
| K183068 | Nitrile Glove Powder Free White | Haining Medical Products Co., Ltd. | LZA | Class I | 2018-12-21 |
| K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | FLL | Class II | 2018-12-21 |
| K182032 | SterilContainer S System | Aesculap, Inc. | KCT | Class II | 2018-12-21 |
| K182320 | BD Contoured Base Pen Needle | Becton, Dickinson and Company | FMI | Class II | 2018-12-20 |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | FMF | Class II | 2018-12-17 |
| K181374 | NRFit Syringe | Jiangsu Caina Medical Co.,Ltd | QEH | Class II | 2018-12-14 |
| K173783 | SCIg60 Infusion System | Emed Technologies Corporation | PKP | Class II | 2018-12-14 |
| K182178 | neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated | LBI | Class II | 2018-12-13 |
| K181174 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | FRG | Class II | 2018-12-11 |
| K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | FLL | Class II | 2018-12-10 |
| K182724 | CelerityTM 10 STEAM Chemical Indicator | STERIS Corporation | JOJ | Class II | 2018-12-10 |
| K163601 | RII Smart IR Thermometer | Radiant Innovation, Inc. | FLL | Class II | 2018-12-06 |
| K173048 | No-contact Forehead Thermometer | Dongguan Simzo Electronic Technology Co., Ltd. | FLL | Class II | 2018-12-06 |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set | Sol-Millennium Medical, Inc. | FMI | Class II | 2018-12-03 |
| K181221 | BD PhaSeal Optima Closed System Transfer Device | Becton, Dickinson and Company | ONB | Class II | 2018-11-30 |
| K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2018-11-30 |
| K180298 | welloStationX | Wello, Inc. | FLL | Class II | 2018-11-30 |
| K180207 | Non-contact Infrared Thermometer | Alicn Medical (Shenzhen), Inc. | FLL | Class II | 2018-11-28 |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | FMZ | Class II | 2018-11-21 |
| K180546 | Jet Power Injectable PICC | Jet Medical, Inc. | LJS | Class II | 2018-11-21 |
| K182133 | Infrared Thermometer | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | 2018-11-20 |
| K182274 | Orbit Subretinal Delivery System | Orbit Biomedical, Inc. | FMF | Class II | 2018-11-20 |
| K182931 | VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag | Steris Corporations | FRC | Class II | 2018-11-20 |
| K182652 | COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 | Kangfu Medical Equipment Factory | FLL | Class II | 2018-11-20 |
| K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Kossan International Sdn Bhd | LZA | Class I | 2018-11-20 |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | Hartalega Sdn Bhd | LZA | Class I | 2018-11-16 |
| K180528 | InstruSafe(R) Sterilization Container | Summit Medical, Inc. | KCT | Class II | 2018-11-16 |
| K182528 | Nitrile Glove Powder Free Black | Haining Medical Products Co., Ltd. | LZA | Class I | 2018-11-15 |
| K181434 | SporView Rapid Read Biological Indicator SteamPlus Test Pack | Crosstex/Spsmedical, A Division of Cantel Medical | FRC | Class II | 2018-11-14 |
| K181369 | Immucise Intradermal Injection System | Terumo Corporation | FMI | Class II | 2018-11-13 |
| K180395 | EZ-IO Intraosseous Vascular Access System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | FMI | Class II | 2018-11-09 |
| K180047 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | FLL | Class II | 2018-11-08 |
| K180381 | Powder Free Vinyl Patient Examination Gloves | Shanxi Hongjin Plastic Technology Co., Ltd. | LYZ | Class I | 2018-11-07 |
| K180683 | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose, Inc. | PQX | Class II | 2018-11-07 |
| K182216 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | 2018-11-06 |
| K182279 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | 2018-11-06 |
| K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff | Hartalega Sdn Bhd | LZA | Class I | 2018-11-02 |
| K182096 | Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs | Owens & Minor Halyard, Inc. | LZA | Class I | 2018-11-02 |
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | Vygon USA | PND | Class II | 2018-11-02 |
| K181239 | Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2018-10-29 |
| K170723 | Swaive Thermometer SWT1A | E-Care Technology Co., Ltd. | FLL | Class II | 2018-10-25 |
| K172670 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | FMF | Class II | 2018-10-23 |
| K172733 | TD-1035 Thermometer | Taidoc Technology Corporation | FLL | Class II | 2018-10-22 |
| K181718 | BD FlowSmart Set/MiniMed Pro-Set | Becton, Dickinson and Company | FPA | Class II | 2018-10-18 |
| K180345 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | QBL | Class II | 2018-10-17 |
| K180468 | SBG Black Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | LZA | Class I | 2018-10-10 |
| K173194 | Temperature Probe | Orantech, Inc. | FLL | Class II | 2018-10-10 |
| K180467 | SBG Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | LZA | Class I | 2018-10-10 |
| K182117 | Vinyl Patient Examination Gloves | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | LYZ | Class I | 2018-10-06 |
| K182115 | Vinyl Patient Examination Gloves | Pingan Medical Products Co., Ltd. | LYZ | Class I | 2018-10-03 |
| K181081 | Infrared Ear Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2018-10-02 |
| K173642 | KLOCKNER SURGICAL BOX | SOADCO, S.L. | KCT | Class II | 2018-10-02 |
| K180964 | Endoscope Sterilization Tray | Intuitive Surgical, Inc. | KCT | Class II | 2018-09-28 |
| K181075 | PureSet Tray | Nobel Biocare AB | KCT | Class II | 2018-09-27 |
| K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims | Eco Medi Glove Sdn. Bhd. | LZA | Class I | 2018-09-26 |
| K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | LJS | Class II | 2018-09-25 |
| K180714 | Probe Covers for Thermometers | K-Jump Health Co., Ltd. | FLL | Class II | 2018-09-24 |
| K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | Hebei Titans Hongsen Medical Technology Co., Ltd. | LYZ | Class I | 2018-09-21 |
| K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | ONB | Class II | 2018-09-21 |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | Amsino International, Inc. | FPA | Class II | 2018-09-05 |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Icu Medical, Inc. | ONB | Class II | 2018-08-31 |
| K181069 | Disposable Insulin Pen Needle | Zhejiang Kindly Medical Devices Co., Ltd. | FMI | Class II | 2018-08-28 |
| K181013 | Fever Scout | VivaLNK, Inc. | FLL | Class II | 2018-08-21 |
| K170824 | BD Vacutainer Eclipse Signal Blood Collection Needle | Becton, Dickinson and Company | FMI | Class II | 2018-08-20 |
| K180574 | Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor | J & J Solutions, Inc. D/B/A/ Corvida Medical | ONB | Class II | 2018-08-17 |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | Hartalega Sdn Bhd | LZA | Class I | 2018-08-17 |
| K173516 | NuBorne Infant Warmer | International Biomedical | FMT | Class II | 2018-08-17 |
| K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | 2018-08-14 |
| K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs | Hebei Titans Hongsen Medical Technology Co., Ltd. | LZC | Class I | 2018-08-10 |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | Hartalega Sdn Bhd | LZA | Class I | 2018-08-10 |
| K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | ONB | Class II | 2018-08-10 |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use | Berpu Medical Technology Co., Ltd. | MEG | Class II | 2018-08-09 |
| K172508 | Ageless Health Medical Digital Thermometer | Ageless Health Industrial Co., Ltd. | FLL | Class II | 2018-08-08 |
| K163578 | EasyTouch Safety Pen Needle | Mhc Medical Products, LLC | FMI | Class II | 2018-08-03 |
| K172280 | BH Sterilization Pouch | Bh Medical Products Co., Ltd. | FRG | Class II | 2018-08-03 |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | MRZ | Class II | 2018-08-02 |
| K180272 | Saniclave 250 | Revolutionary Science | FLE | Class II | 2018-07-26 |
| K172095 | Autokeeper | Medexel Co.,Ltd | FMI | Class II | 2018-07-24 |
15,723 clearances in the General Hospital panel. Data: openFDA.