Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 35
- Latest Decision
- 2023-08-16
Clearances · page 7 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K230314 | Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) | New Era Medicare Sdn. Bhd. | LZA | Class I | 2023-08-16 |
| K230298 | Celsi Monitor | Hadleigh Health Technologies | FLL | Class II | 2023-08-16 |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | Anhui Tiankang Medical Technology Co., Ltd. | NGT | Class II | 2023-08-12 |
| K223584 | Pre-Filled Normal Saline Flush Syringe | Anhui Tianyang Pharmaceutical Co., Ltd. | NGT | Class II | 2023-08-12 |
| K231408 | Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | Shandong Intco Medical Products Co, Ltd. | LZA | Class I | 2023-08-11 |
| K231439 | Powder Free White, Black, and Purple Nitrile Examination Glove | S&S Glove Corporation | LZA | Class I | 2023-08-11 |
| K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | OZW | Class II | 2023-08-11 |
| K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Grand Work Plastic Products Co., Ltd. | LZA | Class I | 2023-08-09 |
| K232008 | Disposable Medical Examination Nitrile Gloves | Raxwell Industrial, LLC | LZA | Class I | 2023-08-08 |
| K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | Steris | JOJ | Class II | 2023-08-07 |
| K223476 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | 2023-08-07 |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | 2023-08-07 |
| K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | KCT | Class II | 2023-08-07 |
| K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | FRG | Class II | 2023-08-07 |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | 2023-08-07 |
| K232010 | iTEMPSHIELD | Aion Biosystems, Inc. | FLL | Class II | 2023-08-04 |
| K231286 | Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. | ONB | Class II | 2023-08-02 |
| K231261 | Altaviz Needle Kit II | Altaviz, LLC | FMI | Class II | 2023-07-27 |
| K231924 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | FMI | Class II | 2023-07-25 |
| K231900 | A-TAP (previously called Arthrotap) | Elcam Medical Acal | FMF | Class II | 2023-07-25 |
| K223752 | Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl | Central Medicare Sdn Bhd | LZA | Class I | 2023-07-24 |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe | Becton, Dickinson and Company | NGT | Class II | 2023-07-21 |
| K221327 | BD Alaris Pump Infusion Sets | Care Fusion | FPA | Class II | 2023-07-21 |
| K231021 | KIMTECH Polaris Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | Kimberly-Clark Corporation | LZA | Class I | 2023-07-21 |
| K221319 | BD Alaris Pump Epidural Infusion Set | Care Fusion | PWH | Class II | 2023-07-21 |
| K223499 | Three Way Stop Cock | M/S Romsons International | FMG | Class II | 2023-07-21 |
| K223037 | Infrared Thermometer, Model: IR8807 | Shen Zhen Rong Feng Technology Co., Ltd. | FLL | Class II | 2023-07-21 |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | Carefusion 303, Inc. | FRN | Class II | 2023-07-21 |
| K230875 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims | Central Medicare Sdn Bhd | LZA | Class I | 2023-07-20 |
| K213100 | FMT Reusable Temperature Probes | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti | FLL | Class II | 2023-07-18 |
| K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | FMF | Class II | 2023-07-18 |
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | Avitus Orthopaedics, Inc. | FMF | Class II | 2023-07-17 |
| K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation | JOJ | Class II | 2023-07-17 |
| K231754 | Praxiject 0.9% NaCl | Medxl, Inc. | NGT | Class II | 2023-07-13 |
| K230680 | Anthogyr Surgical Cassettes | Anthogyr | KCT | Class II | 2023-07-11 |
| K230804 | Complement Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | KCT | Class II | 2023-07-07 |
| DEN220058 | BT-001 | Better Therapeutics | QXC | Class II | 2023-07-07 |
| K231740 | MemorialTM Gloves | Us Glove Supply | LZA | Class I | 2023-07-04 |
| K210924 | e-Celsius Medical System | Bodycap | FLL | Class II | 2023-06-28 |
| K231219 | NobelZygoma PureSet Tray | Nobel Biocare Services AG | KCT | Class II | 2023-06-27 |
| K230492 | Avitus® Precision Autograft Delivery System | Avitus Orthopaedics, Inc. | FMF | Class II | 2023-06-26 |
| K221411 | Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. | FPA | Class II | 2023-06-23 |
| K221827 | Mais Central Venous Catheter | Saudi Mais Co. For Medical Products | FOZ | Class II | 2023-06-23 |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | Cardinal Health200, LLC | MEG | Class II | 2023-06-21 |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | FLE | Class II | 2023-06-21 |
| K223522 | NC° Thermometer (Gen 3), Model Number: NCTG3 | Xiamen Intretech, Inc. | FLL | Class II | 2023-06-20 |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | Ningbo Maxcon Medical Technology Co., Ltd. | MMK | Class II | 2023-06-16 |
| K221121 | Volumat Polyethylene I.V. Administration Set | Fresenius Kabi | FPA | Class II | 2023-06-16 |
| DEN220048 | Neoasis | Invictus Medical, Inc. | QWX | Class II | 2023-06-16 |
| K231023 | ERBEJET® 2 System | Erbe Elektromedizin GmbH | FQH | Class II | 2023-06-15 |
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | FRC | Class II | 2023-06-15 |
| K230718 | UTC 3mL Medication Cartridge | Gilero, LLC | MRZ | Class II | 2023-06-15 |
| K223715 | Celerity Incubator | STERIS Corporation | FRC | Class II | 2023-06-15 |
| K221540 | Synexis Sphere Rx | Synexis, LLC | FRA | Class II | 2023-06-14 |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | LYY | Class I | 2023-06-13 |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shanxi Hongjin Plastic Technology Co., Ltd. | LZA | Class I | 2023-06-09 |
| K230992 | DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. | FPA | Class II | 2023-06-09 |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | PTI | Class II | 2023-06-08 |
| K222248 | Infrared Thermometer | Alicn Medical Shenzhen, Inc. | FLL | Class II | 2023-06-07 |
| K231349 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) | Nephron Nitrile, LLC | LZA | Class I | 2023-06-06 |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | LGZ | Class II | 2023-06-05 |
| K230633 | APOLLO ADVANTAGE Nitrile Examination Gloves | Dell Corning Corporation | LZA | Class I | 2023-06-05 |
| K222702 | RGS; RGS Mini | Genesis Air, Inc. | FRA | Class II | 2023-06-02 |
| DEN220041 | Tristel Duo ULT | Tristel Solutions Limited | QWS | Class II | 2023-06-02 |
| K230635 | Pen Needle | Jiangsu Caina Medical Co.,Ltd | FMI | Class II | 2023-06-02 |
| K220301 | Volumat Line | Fresenius Kabi | FPA | Class II | 2023-06-02 |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) | Ningbo Maxcon Medical Technology Co., Ltd. | MMK | Class II | 2023-06-01 |
| K230542 | Disposable Nitrile Gloves (ABC-DG01) | Huizhou Anboson Technology Co., Ltd. | LZA | Class I | 2023-05-31 |
| K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | QNQ | Class II | 2023-05-31 |
| K230958 | First Glove Blue Nitrile Examination Gloves Powder Free | First Glove Sdn. Bhd. | LZA | Class I | 2023-05-30 |
| K230278 | Babyroo TN300 | Draeger Medical Systems, Inc. | FMT | Class II | 2023-05-30 |
| K230601 | Blue Nitrile Examination Gloves Powder Free | Latrile Gloves Private Limited | LZA | Class I | 2023-05-28 |
| K222640 | Sweden & Martina Surgical Trays | Sweden & Martina S.P.A. | KCT | Class II | 2023-05-26 |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System | Circa Scientific, Inc. | FLL | Class II | 2023-05-25 |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | FMI | Class II | 2023-05-25 |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | MLR | Class II | 2023-05-25 |
| K220759 | Armis VeriCyn Wound Wash | Armis Biopharma, Inc. | FQH | Class II | 2023-05-25 |
| K230564 | Green Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | LZA | Class I | 2023-05-23 |
| K230464 | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | LHI | Class II | 2023-05-22 |
| K223486 | SafeBreak® Vascular | Lineus Medical | QOI | Class II | 2023-05-19 |
| K223645 | I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. | FPA | Class II | 2023-05-18 |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2023-05-17 |
| K220964 | VERSAJET Hydrosurgery System (III) | Smith & Nephew Medical Limited | FQH | Class II | 2023-05-16 |
| K230121 | Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn. Bhd. | LZA | Class I | 2023-05-15 |
| K223101 | BD Secondary Infusion Set | Care Fusion | FPA | Class II | 2023-05-12 |
| K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | FLL | Class II | 2023-05-10 |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. | FRG | Class II | 2023-05-09 |
| K212857 | Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use | Jiangsu Zhiyu Medical Instrument Co, Ltd. | FMF | Class II | 2023-05-09 |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | FRC | Class II | 2023-05-09 |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | Plasmapp Co,., Ltd. | MLR | Class II | 2023-05-09 |
| K223280 | Disposible Nitrile Gloves | Holik Asia Group Co.,Ltd | LZA | Class I | 2023-05-08 |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | FLE | Class II | 2023-05-05 |
| K230616 | Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited | FOZ | Class II | 2023-05-05 |
| K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | QOI | Class II | 2023-05-04 |
| K220713 | Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | 2023-05-04 |
| K222416 | RIA Safeguard | Ria Tech Co., Ltd. | FRF | Class II | 2023-05-01 |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color | Guangdong Kingfa Sci. & Tech.Co., Ltd. | LZA | Class I | 2023-04-27 |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | LZG | Class II | 2023-04-24 |
| K223662 | Neodent Implant System - Helix Short Surgical Kit Cases | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | KCT | Class II | 2023-04-20 |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector | Np Medical, Inc. | FPA | Class II | 2023-04-19 |
15,723 clearances in the General Hospital panel. Data: openFDA.