510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K032131 | Bd Automated Microbiology System Tetracycline - Gp 0.5-16 Ug/ml-Gram Positive Id/ast or Ast Only Phoenix Panels | Becton Dickinson & Co | LON | Class II | |
| K032063 | Pem 2400 Pet Scanner | Pem Technologies | KPS | Class II | |
| K031742 | Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter | Bci, Inc. | DQA | Class II | |
| K030730 | Free Testosterone Enzymeimmunoassay (Eia) Kit | Diagnostics Biochem Canada, Inc. | CDZ | Class I | |
| K030479 | Jms Sysloc A.v. Fistula Needle Set, Jms Sysloc Apheresis Needle Set | JMS North America Corp. | FOZ | Class II | |
| K030429 | Sterrad 200 Sterilizer | Advanced Sterilization Products | MLR | Class II | |
| K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron BV | JAQ | Class II | |
| K032369 | Modification to: Apexpro Telemetry System | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K032168 | Gore-Tex Dualmesh Emerge Plus Biomaterial | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K031958 | Microlife Instant Digital Electronic Thermometer, Model Qt1ja1 | Microlife Intellectual Property GmbH | FLL | Class II | |
| K031157 | Powder-Free Nitrile Examination Glove (Blue) with Natural Water Soluble Vitamin E and Aloe Vera, Peppermint Scented | Qingdao Bestex Rubber & Plastic Products Co., Ltd | LZA | Class I | |
| K030843 | Vpap III | ResMed Corp | BZD | Class II | |
| K023140 | Versa-Kath Epidural Catheter, Model 156-2124 | Epimed International, Inc. | BSO | Class II | |
| K032401 | Orthoview | Omsbar, Ltd. | LLZ | Class II | |
| K032284 | Xive Tg Dental Implant System | Friadent GmbH | DZE | Class II | |
| K032190 | Disposable Powdered Vinyl Exam Gloves | Synmertex Co, Ltd. | LYZ | Class I | |
| K032172 | Disposable Powder Free Vinyl Exam Gloves | Synmertex Co, Ltd. | LYZ | Class I | |
| K032158 | Xive Dental Implant System Multiple | Friadent GmbH | DZE | Class II | |
| K032080 | Rostam Ltd Fragranced Plastic Applicator Tampons | Rostam, Ltd. | HIL | Class II | |
| K031957 | Modification to Karats Multi-Purpose Solution | Alcon Laboratories | LPN | Class II | |
| K031866 | Med-Tec 6 Degree Axis Couch, Model Mt-6Dac | Medtec LLC | JAI | Class II | |
| K031836 | Philips Fresco Release 1 | Philips North America LLC | LLZ | Class II | |
| K031816 | Dvnet Mdv-Pacs | Dvnet International Technology Co., Ltd. | LLZ | Class II | |
| K031814 | Statco2meter, Model 10-55372 | Mercury Medical | CCK | Class II | |
| K031674 | Modification to Frialit-2 Dental Implant System | Friadent GmbH | DZE | Class II | |
| K023014 | Vianox Delivery System, Model I | Pulmonox Medical, Inc. | MRP | Class II | |
| K021560 | Modification to Ameriwater Purification System for Hemodialysis | AmeriWater LLC. | FIP | Class II | |
| K013643 | Ausam Total Albumin Assay | Ausam Biotecthnologies, Inc. | JIQ | Class I | |
| K032370 | Cic Pro Clinical Information Center Central Station | GE Medical Systems Information Technologies, Inc. | DSI | Class II | |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | JIS | Class II | |
| K032246 | Modification to Multitrans Culture Collection and Transport System | Starplex Scientific Corp. | JSM | Class I | |
| K032121 | Modification to E-Scan Xq | Esaote S.p.A. | LNH | Class II | |
| K032073 | Gore Introducer Sheath with Silicone Pinch Valve | W. L. Gore & Associates, Inc. | DYB | Class II | |
| K032000 | Coulter Lh 500 Hematology Analyzer | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K031865 | Vitek 2 Gram Positive Moxifloxacin for Strepococcus Pneumoniae | bioMerieux, Inc. | LON | Class II | |
| K031651 | Modification to Cerasorb Ortho | Curasan AG | MQV | Class II | |
| K031616 | Iur Fluid Management System | Novanta Medical GmbH | HIG | Class II | |
| K031600 | Conduction Catheter | Micor, Inc. | FRN | Class II | |
| K031442 | Pbn Guidewires | Medical Device Technologies, Inc. | DQX | Class II | |
| K021981 | Ivent 201 Portable Ventilator | Versamed, Ltd. | NOU | Class II | |
| K032367 | Itst Intertrochanteric Subtrochanteric Intramedullary Femoral Nail | Zimmer GmbH | HSB | Class II | |
| K032333 | Cryocare Cs Surgical System | Varian Medical Systems, Inc. | GEH | Class II | |
| K032146 | Pvs 1300 Synchro 0.014 & Pvs 1600 Synchro 0.010 Guide Wires | Precision Vascular Systems, Inc. | DQX | Class II | |
| K031770 | Ci Tkr/ukr | Brainlab, Inc. | HAW | Class II | |
| K031713 | Audiometer, Otoacoustic Emission, Auditory Branstem Response Access | Viasys Healthcare GmbH | EWO | Class II | |
| K031331 | Wz Self-Expanding Stent Transhepatic Biliary System | Abbott Vascular | FGE | Class II | |
| K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, Mob-22, Msh-Xx | Imtec Corp. | DZE | Class II | |
| K031068 | Stryker Visum Surgical Lighting System | Stryker Corp. | FSY | Class II | |
| K030639 | Xive 3.0 Dental Implant System | Friandent GmbH | DZE | Class II | |
| K030384 | Evolve Ceramic Radial Head Implant | Wrightmedicaltechnologyinc | KWI | Class II |