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 |
|---|---|---|---|---|---|
| K973317 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | LTT | Class II | |
| K973290 | Syntec True Light Endoillumiinator with Pick | Vaughan Weeks | MPA | Class II | |
| K973185 | American Dental Products Hb-35 Desensitizer with Fluoride | American Dental Products, Inc. | KLE | Class II | |
| K973147 | Npb-295 Pulse Oximeter | Medtronic, Inc. | DQA | Class II | |
| K973087 | Most Hex Intramedullary (I/m) Stem | Sulzer Orthopedics, Inc. | LZO | Class II | |
| K972370 | Rascal Power Chair | Electric Mobility | ITI | Class II | |
| K972109 | Spacemaker Surgicalballoon Dissector/expander | General Surgical Innovations | FZW | Class I | |
| K971359 | Restore (A.k.a. Capsure) | Nebl, Inc. | MNG | Class I | |
| K964540 | Nellcor Puritan Bennett, 740 Ventilator System | Medtronic, Inc. | CBK | Class II | |
| K963756 | Ibc Cardiac Suction Ward | International Biophysics Corp. | DTS | Class II | |
| K954030 | Bone-Lock | Leibinger GmbH | DZE | Class II | |
| K974001 | Aspartate Aminotransferase-Sl Assay, Catalogue Number 319-10, 319-30 | Sekisui Diagnostics P.E.I. Inc. | CIT | Class II | |
| K973898 | Progesterone Elisa | Kmi Diagnostics, Inc. | JLS | Class I | |
| K973897 | Dhea-S | Kmi Diagnostics, Inc. | JKC | Class I | |
| K973824 | Virgo Panco Kit | Hemagen Diagnostics, Inc. | MOB | Class II | |
| K973823 | Pr 3 Antibody Kit | Hemagen Diagnostics, Inc. | MOB | Class II | |
| K973822 | Virgo Anca Screen Kit | Hemagen Diagnostics, Inc. | MOB | Class II | |
| K973770 | Allegiance Kwik Heat Warm Perineal Pack | Medtronic, Inc. | IMD | Class I | |
| K973756 | Eye Sys Vista | Eyesys Technologies, Inc. | HLQ | Class I | |
| K973728 | Silicone Carving Block | Hanson Medical, Inc. | MIB | Class II | |
| K973702 | Elecsys Vitamin B12 Assay | Boehringer Mannheim Corp. | CDD | Class II | |
| K973573 | Duralastic Anatomical Nasal Implants | Hanson Medical, Inc. | FZE | Class II | |
| K973498 | Cynosure Photogenica Er Laser | Cynosure, LLC | GEX | Class II | |
| K973341 | Hook Electrode, Needle Electrode, Coagulation Button Electrode | Richard Wolf Medical Instruments Corp. | GEI | Class II | |
| K973139 | Endopath Ultra-Retractor/ Endopath Vessel Dissector | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K973077 | Plus-Fit Acetabular Cup | Plus Orthopedics | LWJ | Class II | |
| K973065 | Realview Telemedicine System | Vcom Systems, Inc. | LLZ | Class II | |
| K973049 | Imcor Externally Hexed, Self-Tapping Screw Implant Surgical Drilling System | Imcor | DZE | Class II | |
| K972931 | Plus Epf Acetabular Cup | Hhl Consulting | LWJ | Class II | |
| K972769 | Opti-Max Angled Crown Post for Externally-Hexed Implants, in 15 Degree and 25 Degree Inclinations. for Implants 3.3Mm, 4 | Opti-Max | DZE | Class II | |
| K972553 | Lang Dental Resin A97 Fibred Pink | Lang Dental Mfg Co, Inc. | EBI | Class II | |
| K972510 | Pivotal Scissor | Urohealth Systems, Inc. | GEI | Class II | |
| K972446 | Pedo Cush Pedo Cuddle | Cavity Free Kids, Inc. | FMQ | Class I | |
| K972284 | Fluid Management System | Belmont Medical Technologies | FRN | Class II | |
| K972138 | Carr Rigid Container System | Carr Metal Products, Inc. | FRG | Class II | |
| K971893 | Snt Linac Accessories | Surgical Navigation Technologies, Inc. | IYE | Class II | |
| K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | MSX | Class II | |
| K971502 | Serodia Tp-Pa | Scimedx Tekfile Services | GMT | Class II | |
| K970844 | Atomisor | Medical Consulting Service, Inc. | CAF | Class II | |
| K970782 | Imaging Jet System | General Robotic Devices, Inc. | JAB | Class II | |
| K963177 | Ted 191 | Teledyne Brown Engineering | CCL | Class II | |
| K973850 | Alexander Manufacturing Co. Rechargeable Battery #M007 | Alexander Mfg. Co. | HFO | Class II | |
| K973674 | Elecsys Folate | Boehringer Mannheim Corp. | CDD | Class II | |
| K973583 | Ace Theophylline Reagent, Theo Calibrators | Schiapparelli Biosystems, Inc. | KLS | Class II | |
| K973582 | Ace Primidone Reagent, AED Calibrators | Schiapparelli Biosystems, Inc. | DJD | Class II | |
| K973581 | Ace Valproic Acid Reagent, AED Calibrators | Schiapparelli Biosystems, Inc. | LEG | Class II | |
| K973560 | Bone Graft Harvester | Ds Mfg., Inc. | HWE | Class I | |
| K973141 | Heart Access Plus Cardiac Event Recorder | Paceart, Inc. | DXH | Class II | |
| K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | LMD | Class I | |
| K973057 | 1.4 Fr Mapcath Sensor Stylet | Navion Biomedical Corp. | LJS | Class II |