Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 36
- Latest Decision
- 2020-02-21
Clearances · page 18 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | QJY | Class II | 2020-02-21 |
| K190806 | Flowart | Asset Medikal Tasarim As. | FPA | Class II | 2020-02-20 |
| K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | LJS | Class II | 2020-02-20 |
| K192674 | Mixing and Delivery System | Bone Solutions, Inc. | FMF | Class II | 2020-02-18 |
| K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | NGT | Class II | 2020-02-13 |
| K191829 | Microlife Non-Contact Infrared Forehead Thermometer | Microlife Intellectual Property GmbH | FLL | Class II | 2020-02-13 |
| K191689 | EleGARD Patient Positioning System | Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio | FOA | Class I | 2020-02-13 |
| K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack | 3M Company | FRC | Class II | 2020-02-07 |
| K192785 | OptiScanner® 5000 Glucose Monitoring System | Optiscan Biomedical Corporation | LZF | Class II | 2020-02-05 |
| K190962 | Bella-mu | U-Needle B.V. | FMI | Class II | 2020-02-03 |
| K193192 | Tamper Evident Cap | International Medical Industries, Inc. | FMF | Class II | 2020-01-31 |
| K192333 | Blue Nitrile Examination Gloves Powder Free | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LZA | Class I | 2020-01-24 |
| K192641 | Gemini Titan Sterilization Wrap | Medline Industries, Inc. | FRG | Class II | 2020-01-24 |
| K192493 | BD Cathena (TM) Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2020-01-24 |
| K192349 | Bactisure Wound Lavage | Next Science, LLC | FQH | Class II | 2020-01-23 |
| K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | Advanced Sterilization Products (Asp) | FRC | Class II | 2020-01-23 |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | FMT | Class II | 2020-01-21 |
| K192985 | Medline Glide-On 3G Vinyl Examination Gloves | Medline Industries, Inc. | LYZ | Class I | 2020-01-21 |
| K192635 | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) | Wrp Asia Pacific Sdn. Bhd. | LZA | Class I | 2020-01-17 |
| K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | LZA | Class I | 2020-01-10 |
| K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | Ever Growth (Vietnam) Co. , Ltd. | LZA | Class I | 2020-01-07 |
| K191642 | TK Sterile Piston Syringe without Needle | Anhui Tiankang Medical Technology Co., Ltd. | FMF | Class II | 2020-01-06 |
| K191195 | PiccGuard | Piccguard, LLC | PZW | Class II | 2020-01-03 |
| K192444 | mCare® Powder Free Nitrile Black Examination Glove | Mercator Medical (Thailand), Ltd. | LZA | Class I | 2019-12-31 |
| K190990 | Digital Thermometer | Xiamen Ants Bro Technology Co., Ltd. | FLL | Class II | 2019-12-31 |
| K190736 | Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs | Ever Growth (Vietnam) Co. , Ltd. | LZA | Class I | 2019-12-23 |
| K193254 | 3M Attest Steam Chemical Integrator | 3M Company | JOJ | Class II | 2019-12-23 |
| K192104 | Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) | Medline Industries, Inc. | LZA | Class I | 2019-12-23 |
| K190665 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2019-12-23 |
| K190860 | Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color | Ever Growth (Vietnam) Co. , Ltd. | LZA | Class I | 2019-12-23 |
| K192487 | EZ-TRAX Containment Device | K1 Medical, LLC | KCT | Class II | 2019-12-23 |
| K191643 | TK Sterile Hypodermic Needle | Anhui Tiankang Medical Technology Co., Ltd. | FMI | Class II | 2019-12-19 |
| K192670 | Neodent Instrument Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2019-12-18 |
| K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | Riverstone Resources Sdn Bhd | LZA | Class I | 2019-12-17 |
| K190717 | Infrared Thermometer, model: PC808 | Shenzhen Pacom Medical Instruments Co., Ltd. | FLL | Class II | 2019-12-13 |
| K192647 | neria guard Infusion Set | Unomedical A/S | FPA | Class II | 2019-12-13 |
| K192929 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | MED | Class II | 2019-12-10 |
| K192533 | Health Line CT CVC | Health Line International Corporation | FOZ | Class II | 2019-12-10 |
| K183052 | ID-Cap System | Etectrx, Inc. | OZW | Class II | 2019-12-06 |
| K191522 | Straumann Modular Cassette | Institut Straumann AG | KCT | Class II | 2019-12-03 |
| K190987 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | QBL | Class II | 2019-12-02 |
| K190876 | mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed | Mercator Medical (Thailand), Ltd. | LZA | Class I | 2019-12-02 |
| K182819 | Decanting Device | Gcmedica Enterprise Ltd.(Wuxi) | LHI | Class II | 2019-12-02 |
| K192329 | Blue Latex Examination Powder Free Gloves | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | LYY | Class I | 2019-11-25 |
| K181845 | Pivot System Sterilization case | Rp Medical, Inc. | KCT | Class II | 2019-11-25 |
| K190494 | Infant Incubator | Ningbo David Medical Device Co., Ltd. | FMZ | Class II | 2019-11-25 |
| K191236 | 3M Attest Steam Chemical Integrators | 3M Company | JOJ | Class II | 2019-11-22 |
| K191488 | SAM IO Intraosseous Access System | Sam® Medical Products, Inc. | FMI | Class II | 2019-11-21 |
| K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | Avenir Performance Europeenne Medical (Apem) | LHI | Class II | 2019-11-19 |
| K183393 | Digital Thermometer | Joytech Healthcare Co. , Ltd. | FLL | Class II | 2019-11-18 |
| K192937 | 3M Comply Hydrogen Peroxide Chemical Indicator | 3M Company | JOJ | Class II | 2019-11-16 |
| K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | FMI | Class II | 2019-11-13 |
| K191570 | Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd. | FLL | Class II | 2019-11-13 |
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | O&M Halyard, Inc. | LZC | Class I | 2019-11-08 |
| K192232 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2019-11-08 |
| K190541 | MTS225 and MTS300 Multiple Tray Sterilization Systems | Pmbs, LLC | KCT | Class II | 2019-11-05 |
| K191292 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Anhui Powerguard Technology Co., Ltd. | LYZ | Class I | 2019-11-05 |
| K190013 | WellDoc BlueStar | Welldoc, Inc. | MRZ | Class II | 2019-11-04 |
| K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) | Sturdy Industrial Co., Ltd. | FLE | Class II | 2019-11-01 |
| K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined Bd) | FOZ | Class II | 2019-11-01 |
| K191896 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | FLE | Class II | 2019-10-31 |
| K192802 | primeMidline Catheters | Pfm Medical, Inc. | PND | Class II | 2019-10-28 |
| K192673 | 3M Comply Hydrogen Peroxide Indicator Tape 1228 | 3M Company | JOJ | Class II | 2019-10-28 |
| K191258 | Intraosseous infusion device | Einstein Works, LLC | FMI | Class II | 2019-10-23 |
| K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | Encompass Industries Sdn. Bhd. | LZC | Class I | 2019-10-23 |
| K190157 | Diana ChemoClave Transfer Set | Icu Medical | ONB | Class II | 2019-10-23 |
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Sterilucent, Inc. | FRC | Class II | 2019-10-22 |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile | Monumedical, LLC | FMG | Class II | 2019-10-22 |
| K190054 | BD Insulin Syringe | Becton, Dickinson and Company | FMF | Class II | 2019-10-21 |
| K191999 | Sterilucent VH2O2 Chemical Indicators | Sterilucent, Inc. | JOJ | Class II | 2019-10-21 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | LZG | Class II | 2019-10-21 |
| K191283 | Infrared Thermometer, Breeze model | Suzhou Melodicare Medical Technology Co., Ltd. | FLL | Class II | 2019-10-18 |
| K192325 | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | LGZ | Class II | 2019-10-18 |
| K191668 | Infrared Forehead Thermometer (Model IR-FT) | Comper Chuangxiang (Beijing) Technology Co., Ltd. | FLL | Class II | 2019-10-18 |
| K190149 | Vial Adapter Ø20 mm | Avenir Performance Europeenne Medical (Apem) | LHI | Class II | 2019-10-15 |
| K191251 | Infared Thermometer | Shenzhen Calibeur Industries Co., Ltd. | FLL | Class II | 2019-10-15 |
| K190840 | Medtronic Transportation / Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | KCT | Class II | 2019-10-15 |
| K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall | Terumo Europe N.V. | FMI | Class II | 2019-10-11 |
| K182184 | Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) | Mdk (Shanghai) Medical Packing Co., Ltd. | FRG | Class II | 2019-10-10 |
| K192147 | Halyard ONE-STEP* Sterilization Wrap | Owens & Minor (O&M) Halyard, Inc. | FRG | Class II | 2019-10-10 |
| K192210 | ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System | Fiab Spa | FLL | Class II | 2019-10-10 |
| K191659 | Instylla Delivery Kit | Instylla, Inc. | FMF | Class II | 2019-10-10 |
| K191359 | Nipro Syringe | Nipro Medical Corporation | FMF | Class II | 2019-10-09 |
| K190538 | NIO-I | Waismed, Ltd. | FMI | Class II | 2019-10-07 |
| K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | Semperit Investments Asia Pte , Ltd. | LZA | Class I | 2019-10-04 |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | MEG | Class II | 2019-10-04 |
| K191490 | Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe | Jiangsu Caina Medical Co.,Ltd | MEG | Class II | 2019-10-03 |
| K192421 | EpiFaith Syringe | Flat Medical Co., Ltd. | FMF | Class II | 2019-09-27 |
| K190466 | PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate | Shen Wei USA, Inc. | LZA | Class I | 2019-09-26 |
| K190454 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2019-09-26 |
| K190001 | Supercath 5 | Togo Medikit Co., Ltd. | FOZ | Class II | 2019-09-20 |
| K191232 | AccuCath Ace Intravascular Catheter | C.R. Bard, Inc. | FOZ | Class II | 2019-09-18 |
| K191800 | Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim | Kossan International Sdn Bhd | LZA | Class I | 2019-09-16 |
| K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | Medline Industries, Inc. | NGT | Class II | 2019-09-15 |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide Sterilizer | Sterilucent, Inc. | MLR | Class II | 2019-09-13 |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | Terragene S.A. | FRC | Class II | 2019-09-13 |
| K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use | Shanghai Kohope Medical Devices Co., Ltd. | FMF | Class II | 2019-09-12 |
| K183444 | Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector | Cenorin, LLC | LDS | Class II | 2019-09-09 |
| K190403 | Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | 2019-09-06 |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | Jiangsu Micsafe Medical Technology Co., Ltd. | MEG | Class II | 2019-09-06 |
15,723 clearances in the General Hospital panel. Data: openFDA.