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 |
|---|---|---|---|---|---|
| K902214 | Biopsy Needle Transponder System | Advanced Technology Laboratories, Inc. | IYO | Class II | |
| K901659 | Titanium Greenfield(r) Vena Cava Filter W/hooks | Boston Scientific Corporation | DTK | Class II | |
| K901598 | Fastidious Mic Panel | Microtech Medical Systems, Inc. | JWY | Class II | |
| K904913 | Handi-Trak Wheelchair Snow Chains | Handi-Trak, Inc. | KNN | Class I | |
| K904818 | Xcaliber | Everest & Jennings, Inc. | ITI | Class II | |
| K904714 | Ciba Corning Acs Prolactin Immunoassay | Ciba Corning Diagnostics Corp. | CFT | Class I | |
| K904320 | Sterile Surgeons Gloves (Ultra-Touch-Latex) | R.K.F. Laboratories, Inc. | KGO | Class I | |
| K904093 | Buccal Tube, Buccal Attachment | Lancer Orthodontics, Inc. | EJF | Class I | |
| K904067 | Lasersat CO2 | Satelec | GEX | Class II | |
| K903821 | Psc-1 W/other Numerical | Eigen | JAA | Class II | |
| K903813 | Ureteral Balloon Dilatation Catheter | Boston Scientific Corporation | EZN | Class II | |
| K903701 | Xpress | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K903625 | Doppler Needle and Flow Monitor | Peripheral Systems Group | DPW | Class II | |
| K903623 | Model600 Uterine Activity Monitor | Corometrics Medical Systems, Inc. | HFM | Class II | |
| K903613 | Harvard/lte Benchtop Steam Sterilizer (Autoclave) | Harvard Apparatus, Inc. | FLE | Class II | |
| K903159 | Valve Controller for Micromacro Compounder | Baxa Corp., Sub. of Cook Group, Inc. | LHI | Class II | |
| K903139 | Beamview & Beamview Plus (Aka Project 743) | Siemens Medical Laboratories, Inc. | IYE | Class II | |
| K902981 | G.e. Fluorocon 300 Imaging System | Electromek Diagnostic Systems, Inc. | JAA | Class II | |
| K902099 | Wilson-Cook Varices Tamponade Balloon Cuff | Wilson-Cook Medical Inc. | KNT | Class II | |
| K904815 | Qms Tm- Phenytoin | Seradyn, Inc. | DIP | Class II | |
| K904623 | Radiographic Transport, Trauma Model 056-230, 235 | Atomic Products Corp. | IXQ | Class II | |
| K904387 | Bioclones Elegance Lh Elisa Kit | Bioclone Australia Pty, Ltd. | CEP | Class I | |
| K904307 | Dupont Salicylate Calibrator | E.I. Dupont de Nemours & Co., Inc. | DLJ | Class II | |
| K904033 | Reflotron Potassium Test Tabs | Boehringer Mannheim Corp. | CEJ | Class II | |
| K903582 | Echomark Pta Ultrasonically Located Balloon Cath. | Catheter Sciences Co. | LIT | Class II | |
| K903560 | Clarke Laparoscopic Ligator and Forceps | Marlo Surgical Technology | HET | Class II | |
| K903441 | Mydas(tm) Brand Solid-Phase Antibody Reagents | Intl. Immunoassay Laboratories, Inc. | JHX | Class II | |
| K902983 | Siemen's Siremobile II C-Arm | Electromek Diagnostic Systems, Inc. | JAA | Class II | |
| K904862 | Handi-Traction | Handi-Trak, Inc. | ITI | Class II | |
| K904817 | Magnum | Everest & Jennings, Inc. | ITI | Class II | |
| K904803 | Cap-Evac Adapter | Logan, Inc. | CBN | Class II | |
| K904483 | Elegance Prolactin Elisa | Bioclone Australia Pty, Ltd. | CFT | Class I | |
| K904413 | Cedia(tm) Phenobarbital Assay | Microgenics Corporation | LAF | Class II | |
| K904334 | Percutaneous Intravenous Catheter Repair Kit | Pharmacia Deltec, Inc. | LJS | Class II | |
| K904225 | Kwikmix | Baxa Corp., Sub. of Cook Group, Inc. | LHI | Class II | |
| K904197 | Childrens Sunglasses | Jasco Products Co., Inc. | HQY | Class I | |
| K904091 | Titanal,sterling Spring,dual Flex,memorex,bendallo | Lancer Orthodontics, Inc. | EJF | Class I | |
| K903878 | Mentor(r) Durastat(tm) Autoclav Bipolar Hemostat | Mentor O & O, Inc. | HQQ | Class II | |
| K903646 | Gastrograph | Medics Instrument Corp. | FFT | Class I | |
| K903555 | Electrotrace Disposable Ag/agcl EKG Mon. Elec. | Jason Marketing Co. | DRX | Class II | |
| K903487 | Solarshields Encore | Dioptics | HQY | Class I | |
| K903149 | Chanllenge 1010 Patient Key Program Station | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | |
| K903056 | Bacttrap | Pharma Systems AB | CAH | Class II | |
| K902771 | Arterial Blood Sampling Kit | Medex, Inc. | DQO | Class II | |
| K902654 | Cdi (Tm) System 100 Monitoring System | 3M Company | DTY | Class II | |
| K902397 | Modulock Posterior Spinal Fixation | Zimmer GmbH | KWP | Class II | |
| K902119 | Safebris Sterile Circumcision Kit | Kedumin Kits, Ltd. | FHJ | Class II | |
| K901587 | Tsrh Sacral L-Connector | Danek Medical, Inc. | KWP | Class II | |
| K901064 | Monohaem (Fecal Occult Blood Test) | Silenus Laboratories Proprietary, Ltd. | KHE | Class II | |
| K901015 | Wright Pocket Dopplers Vascular & Obstetric | Wright Medical | DPW | Class II |