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 |
|---|---|---|---|---|---|
| K970590 | N/a | North American Technical Services Corp. | ILY | Class II | |
| K970507 | Peak Flow Meter | Intl. Medical, Inc. | BZH | Class II | |
| K964785 | Veridose Diodes | Victoreen, Inc. | IYE | Class II | |
| K964507 | Roche Cobas Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems Inc | MKZ | Class I | |
| K964025 | Mitaya Aluminum Interspaced X-Ray Grid | X-Ray Accessory Corp. | IXJ | Class I | |
| K963575 | Hbf-1000 Omron Body Composition Analyzer | Omron Healthcare Co., Ltd. | MNW | Class II | |
| K963349 | Devilbiss 8650D | Devilbiss Health Care, Inc. | BTI | Class II | |
| K962597 | Lxn Fructosamine Test System | Lxn Corp. | LCP | Class II | |
| K961787 | Body Composition Software Option for Qdr X-Ray Bone Densitometers | Hologic, Inc. | KGI | Class II | |
| K961779 | Mini-Bell Peak Flow Meter/low Range Model Peak Flow Meter | Avion Medical Products, Inc. | BZH | Class II | |
| K925501 | Nylon Coated Specula | Zinnanti Surgical Instruments, Inc. | HIB | Class II | |
| K971954 | Liquichek Urine Chemistry Control (Cat.no. 397,398) | Bio-Rad | JJY | Class I | |
| K971886 | Accutest Hcg-Urine | Unotech Diagnostics, Inc. | JHI | Class II | |
| K971817 | Olympus Ck-Mb Reagent | OLYMPUS Corporation of the Americas | JLB | Class I | |
| K971713 | N-Acetylprocainamide Assay for the Bayer Immuno 1 System | Bayer Corp. | LAN | Class II | |
| K971674 | Valleylab Single Use Solid Laparoscopic Elec. Spatula (Straight & Curved) J&l Hook, Ball Conmed Solid Shaft Electrode St | Apyx Medical Corporation | GEI | Class II | |
| K971505 | Synchron Systems Cholesterol (Chol) Reagent | Beckman Instruments, Inc. | CHH | Class I | |
| K971444 | 3M Red Dot 2234 & 2266 Radiolucent Monitoring Electrodes | 3M Medical Products Group | DRX | Class II | |
| K971334 | Pilling Weck Secondary Flexible Sleeve with Trocar | Pilling Weck Group | GCJ | Class II | |
| K971248 | Kaneda Sr Anterior Spinal System | Acromed Corp. | KWQ | Class II | |
| K971061 | Opportunity Inc. Bone Marrow Biopsy and Aspiration Tray | Opportunity, Inc. | LRO | Class II | |
| K970955 | Acromed Anterior Cervical Stabilization System | Acromed Corp. | KWQ | Class II | |
| K970934 | Cb Erbium/2.94(tm) Er:yag Laser | Continuum Biomedical, Inc. | GEX | Class II | |
| K970177 | Anti-Cardiolipin Antibody (Aca) Screen Elisa | Immco Diagnostics, Inc. | MID | Class II | |
| K965173 | Duration Stabilized Uhmwpe Knee Components | Howmedica Corp. | JWH | Class II | |
| K964842 | Immage Immunochemistry System Complementc3 (C3) and Complementc4 (C4) Reagent | Beckman Instruments, Inc. | CZW | Class II | |
| K963653 | Wallach Quantum 2000 Electrosurgical System | CooperSurgical, Inc. | HGI | Class II | |
| K963612 | Duration Stabilized Uhmwpe | Howmedica Corp. | JDI | Class II | |
| K961711 | Aspisafe Gastric Tube | B.Braun Medical, Inc. | BSS | Class II | |
| K960724 | Bio-Gide Resorbable Bilayer Membrane | Geistlich Pharma AG | NPK | Class II | |
| K971887 | Breath Taker | Hofa, LLC | LCN | Class I | |
| K971468 | Scar Heal | Specialty Systems, Inc. | MDA | Class I | |
| K970954 | O.b. Applicator Tampons | Personal Products Co. | HEB | Class II | |
| K970946 | Medline Y-Type Tur/bladder Irrigation Set | MEDLINE INDUSTRIES, LP - Northfield | LJH | Class II | |
| K970917 | Solos 10Mm Operating Laparoscope | Woodbine Optical Corp. | GCJ | Class II | |
| K970528 | Clyde Coronary Guidewire | Schneider (Europe) GmbH | DQX | Class II | |
| K964679 | White River Automatic Breast Pump | White River Concepts | HGX | Class II | |
| K963717 | Millex - Mp Filter Unit (Slmpo25ss/slmpl25ss) | EMD Millipore Corporation | BSN | Class II | |
| K952172 | Hotman | Hemo Sapiens, Inc. | DSB | Class II | |
| K971064 | Bayers Bimanual I/a Handpieces | Visioncare Devices, Inc. | HQC | Class II | |
| K971062 | Opportunity Inc. General Purpose Tray | Opportunity, Inc. | LRO | Class II | |
| K970929 | Depuy Low Profile Bone Screw | Depuy, Inc. | HWC | Class II | |
| K970896 | Mitek 3.5 Mm Panalok Wedge Absorbable Suture Anchor System | Ethicon, Inc | MAI | Class II | |
| K964805 | Bio-Anchor | Linvatec Corporation | MAI | Class II | |
| K964005 | Synergetics Synerlight Fiber Optic Lightsource | Synergetics Inc | MPA | Class II | |
| K971804 | Philips S1694, S1695 | Philips Hearing Instruments Co. | ESD | Class I | |
| K971701 | Continu-Flo Solution Set | Baxter Healthcare Corporation | FPA | Class II | |
| K971693 | Rionet Hb-79P | Authorized Hearing Systems, Inc. | ESD | Class I | |
| K971535 | Widex Senso Digital (Mini Canal) | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K971382 | Prone Breast Positioning Board, Model #37-018 | Victoreen, Inc. | IYE | Class II |