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 |
|---|---|---|---|---|---|
| K970649 | Hero 642 | Micro-Mega SA | EKS | Class I | |
| K970596 | Dhd Emerald Product | Dhd Diemolding Healthcare Div. | BWF | Class II | |
| K970362 | Care Tec Portable Low Air Loss Therapy System | Apex Metal, Inc. | FNM | Class II | |
| K970295 | Flexicair Exlipse Plus | Hill-Rom Inc. | IOQ | Class II | |
| K964605 | Braun Thermoscan Pro-2000 Instant Thermometer (Pro-2000) | Thermoscan, Inc. | FLL | Class II | |
| K963767 | Manan V.s. Access Needle/set | Argon Medical Devices, Inc | FGE | Class II | |
| K953647 | Ms Classique Balloon Catheter W/hydropass Coating | Meadox Medicals, Div. Boston Scientific Corp. | LIT | Class II | |
| K971390 | Quantum 3080Sp Surgical Table | STERIS Corporation | GDC | Class I | |
| K971148 | 700-Sp Series Disposable Stimulation Electrodes | Cardiotronics Systems, Inc. | MKJ | Class III | |
| K970639 | Neuroline, Disposable Reference and Recording Electrodes Type No: 72000-S, 72010-K | Medicotest, Inc. | GXY | Class II | |
| K964832 | Hewlett-Packard Centralvue Software | Hewlett-Packard Co. | DSI | Class II | |
| K964584 | Ambu Spur Neonate | Ambu, Inc. | BTM | Class II | |
| K963904 | P.h.d. - Personal Heart Device Model 5258 | Heart Alert, Inc. | DXH | Class II | |
| K971452 | Multix Top/pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | IZZ | Class II | |
| K971365 | Philips Integris H5000 | Philips North America LLC | IZI | Class II | |
| K971109 | Quikpac II One Step Amphetamine Test | Drial Consultants, Inc. | DKZ | Class II | |
| K971000 | Epistaxis Nasal Pack | Invotec International, Inc. | EMX | Class I | |
| K970947 | B-350 Ceiling Mounted C-Positioner | Omega Medical Imaging, LLC | JAA | Class II | |
| K970881 | Cedia Digoxin | Boehringer Mannheim Corp. | KXT | Class II | |
| K970850 | Scanrite Dfs | Scanrite Systems | EHD | Class II | |
| K970799 | Alexander Manufacturing Rechargeable Battery (M1/t) | Alexander Mfg. Co. | LIF | Class II | |
| K970787 | Alexander Mfg. Rechargeable Battery (Model M3) | Alexander Mfg. Co. | DPS | Class II | |
| K970784 | Alexander Mfg. Rechargeable Battery (Model M3/t) | Alexander Mfg. Co. | DXG | Class II | |
| K970694 | Model 1700, Hydro Prep | Physiometrix, Inc. | GYB | Class II | |
| K970562 | Tenosnare | Luxtec Corp. | HRX | Class II | |
| K970522 | Myerson's Economy Denture Base Material | Austenal, Inc. | EBI | Class II | |
| K970428 | Rest X System | Restxsys | FNM | Class II | |
| K965232 | Caltag Cal-Lyse | Caltag Laboratories, Inc. | GKZ | Class II | |
| K965052 | D3 (Phemfilcon a) UV Optifit Toric (Hydrophilic) Contact Lenses | Wesley Jessen Corp. | LPL | Class II | |
| K964961 | Model 405T with Etco2 Option | Ivy Biomedical Systems, Inc. | CCK | Class II | |
| K964869 | Neurosign 800, 8 Channel Motor Nerve Monitor | Magstim Inc. | ETN | Class II | |
| K964796 | Odyssey I Dental Water Unit | Germiphene Corp. | EIA | Class I | |
| K964518 | Fast-Cath Transseptal Catheter Introducer | Daig Corp. | DYB | Class II | |
| K971412 | Sunglasses | Team Chien Industrial Co., Ltd. | HQY | Class I | |
| K971208 | Medline Industries, Inc. Orthopedic Trays/kits/packs | MEDLINE INDUSTRIES, LP - Northfield | GAM | Class II | |
| K971041 | Chase Coronary Ostial Perfusion Cannula | Chase Medical, Inc. | DWF | Class II | |
| K970914 | Chase Aortic Perfusion Cannula | Chase Medical, Inc. | DWF | Class II | |
| K970724 | Quickpac II One Step Methamphetamine Test | Drial Consultants, Inc. | DKZ | Class II | |
| K970699 | Aurora Sunglasses,ski Goggles and Protective/saftey Goggles | Yeong Jiuh Corp. | HQY | Class I | |
| K970667 | Nuvo-Lase 660 Laser System | American Laser Medical | GEX | Class II | |
| K964553 | Mbi Co-Axial Illuminated Retinal Pick | M.B. Industries, Inc. | MPA | Class II | |
| K964405 | Mbi Illuminated Retinal Pick | M.B. Industries, Inc. | MPA | Class II | |
| K964391 | Chase Left Vent Safety Valve | Chase Medical, Inc. | DWF | Class II | |
| K964132 | Modification to Otoacoustic Emissions (Oae0 Test Instrument | Bio-Logic Systems Corp. | EWO | Class II | |
| K971353 | Dsl Active Non-Extraction Igf-I Elisa | Diagnostic Systems Laboratories, Inc. | CFL | Class I | |
| K971239 | Greiner Vacuette Blood Collection Tube | Greiner America, Inc. | JKA | Class II | |
| K971236 | Greiner Vacuette Blood Collection Tube | Greiner America, Inc. | JKA | Class II | |
| K970702 | Spectrum Designs Spectragel | Spectrum Designs, Inc. | MDA | Class I | |
| K970628 | Ge Advantage Digitizer Workstation | GE Healthcare | LMD | Class I | |
| K970586 | Brainlab Micro Multi-Leaf Collimator | Brainlab Med. Computersysteme GmbH | IYE | Class II |