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 |
|---|---|---|---|---|---|
| K982946 | Painbuster Infusion Kit | Halyard Health | MEB | Class II | |
| K982745 | Auto-Lyte Barbiturates Eia | OraSure Technologies, Inc. | DIS | Class II | |
| K982657 | Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100 | Microvena Corp. | MCW | Class II | |
| K982431 | Nmt Safety Syringe | New Medical Technology, Ltd. | MEG | Class II | |
| K982362 | Abbott Testpack Plus H. Pylori | Abbott Medical | LYR | Class I | |
| K982315 | Prospect Campylobacter Microplate Assay | Alexon - Trend, Inc. | LQP | Class I | |
| K981199 | Microscan Dried Gram Negative Mic/combo Panels , Esbl Screen | Dade Microscan, Inc. | LRG | Class II | |
| K983855 | Fuzzy Type Digital Blood Pressure Monitor, Model #'S Hd-1000S & Hd-2000F | Jawon Medical Co., Ltd. | DXN | Class II | |
| K983125 | Epidural Catheter Models 1210/1200 | Rusch Intl. | CAZ | Class II | |
| K983048 | American Electromedics Quik Tymp 2 (Qt2) Tympanometer/audiometer with Integral Printer | American Electromedics Corp. | EWO | Class II | |
| K983046 | American Electromedics Race Car Tympanometer W/integral Printer | American Electromedics Corp. | ETY | Class II | |
| K982168 | Solo-Care Brand Multi-Purpose Solution | Alcon Laboratories | LPN | Class II | |
| K981853 | Bone Injection Gun (B.i.g.) Device | Waismed Ltd. | FMI | Class II | |
| K980551 | Silenzio Delta Continuous Positive Airway Pressure System | Nidek Medical Products Inc | BZD | Class II | |
| K980492 | Aeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F) | Circon Acmi | FFK | Class II | |
| K983980 | Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia Calls | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K983848 | Abbott Axsym Myoglobin | Abbott Medical | DDR | Class II | |
| K983812 | Napa Eia Assay | Diagnostic Reagents, Inc. | LAN | Class II | |
| K983659 | Planmed Sophie & Planned Sophie Classic | Planmed Oy | IZH | Class II | |
| K983617 | 25-Hydroxyvitamin D 125I Ria Kit | Diasorin Inc. | LCI | Class I | |
| K983428 | Safetex Cervical Scraper (Plastic) | Andwin Scientific | HHT | Class II | |
| K983380 | Durex Lubragel Latex Condom | London Intl., LLC | HIS | Class II | |
| K983181 | Cytoprep | Cytoprep Inc. Est. | HHI | Class II | |
| K983143 | Mark 5000 Phased Array Shoulder Coil | GE Healthcare Coils | MOS | Class II | |
| K983111 | XRAY Vision | Apteryx, Inc. | LLZ | Class II | |
| K982994 | Skull Base Instatrak System | Visualization Technology, Inc. | LLZ | Class II | |
| K982972 | Signa Profile Small Head Coil | GE Healthcare | MOS | Class II | |
| K982924 | Durex Sensidom Latex Condom | London Intl., LLC | HIS | Class II | |
| K982911 | Forte | Philips North America LLC | KPS | Class II | |
| K982610 | Olympus Um-2R/3r Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) | Olympus Optical Co., Ltd. | ITX | Class II | |
| K980182 | Water Purification System for Hemodialysis | Usfilter/Ionpure, Inc. | FIP | Class II | |
| K980045 | Centurion Central Station Arrhythmia Patient Monitoring System | Invivo Research, Inc. | DSI | Class II | |
| K983786 | Sterngold Implamed Wide Platform Dental Implants and Related Prosthetics and Insttumentation | Sterngold/Implamed | DZE | Class II | |
| K983582 | Cardiobeeper Cb250 | Merdian Medical Technologies, Ltd. | DXH | Class II | |
| K983361 | Panavia F | Kuraray America, Inc. | EMA | Class II | |
| K983357 | Mucopren Soft Relining System | Roydent Dental Products, Inc. | EBI | Class II | |
| K983135 | Blower/mister | Cardiothoracic Systems, Inc. | FQH | Class II | |
| K983085 | Hemocor Hph 700 Hemoconcentrator | Medivators Inc | KDI | Class II | |
| K983028 | Fracture Risk Option for the Qdr Bone Densitometer, Model#s Qdr4500, Qdr2000, Qdr1500, Qdr4000, Qdr1000, Qdr1000w | Hologic, Inc. | KGI | Class II | |
| K983021 | Metrosoft II, Metrosoft Toric, Metrolite, Metrotint, Satureyes, Satureyes Toric, Satureyes Lite, Satureyes Lite Toric | Metrosoft, Inc. | LPL | Class II | |
| K982803 | Heartlink, Model II | Cardiac Telecom Corp. | QYX | Class II | |
| K981964 | Medi-Trace 4103 Neonatal Electrode | Graphic Controls Corp. | DRX | Class II | |
| K973171 | Nir Biliary Stent | Medinol Ltd. | FGE | Class II | |
| K970811 | Disposable Cannula Tracheostomy Tube, with Inner Cannula;disposable Cannula Fenestrated Tracheostomy Tube, with Inner Cn | Pneumocare, Inc. | JOH | Class II | |
| K983771 | Strategy Coronary Wire Guide | Cook Inc. | DQX | Class II | |
| K983706 | Modification of Townley Pedicle Screw Plating System | Sofamor Danek USA,Inc. | KWP | Class II | |
| K983602 | Cv Peri-Guard and Vascu-Guard | Bio-Vascular, Inc. | DXZ | Class II | |
| K983578 | Architect Testosterone Mastercheck, Model 6C28-05 | Bio-Rad | JJX | Class I | |
| K983517 | Safe-T-Fill Capillary Blood Collection System | Ram Scientific | JKA | Class II | |
| K983460 | Star Automated Multi-Parametric Analyzer | American Bioproducts Co. | JPA | Class II |