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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K810496 | Veri/pms Model 815 | Verite | IPF | Class II | |
| K810490 | Gomco Suction Pump Cabinet Change | Allied Medical LLC | BTA | Class II | |
| K810480 | Scanlan Suture Boots | Scanlan Intl., Inc. | KOC | Class II | |
| K810433 | Lower Extremity Support System-Less | Walgen Medical Innoventions | FWZ | Class I | |
| K810432 | Cordis Pervenous Atrial Lead | Cordis US Corp. | DTB | Class III | |
| K810430 | Venturi Mask/delivery System #6078 | Todd Industries, Inc. | BYF | Class I | |
| K810428 | Vicryl | Ethicon, Inc | FTL | Class II | |
| K810386 | Thinlith II Pulse Gneerator Model 227-05 | Intermedics, Inc. | DXY | Class III | |
| K810374 | Corrugated Flex Tubing #6000, | Todd Industries, Inc. | BYX | Class I | |
| K810359 | Electroencephalomyograph | Thoracel Research Labs. | OLT | Class II | |
| K810333 | Temporary Myocardial Pacing Lead#6400 | Medtronic, Inc. | DTB | Class III | |
| K810305 | Datason Db Ultrasound Imaging System | General Electric Co. | HEM | Class II | |
| K810257 | Vessel Tips, Sizes 13-18 | Quinton, Inc. | FKW | Class II | |
| K810236 | Miromed Peritoneal Dialysis Catheter | American Medical Products LLC | FJS | Class II | |
| K803275 | Kpp Peritoneal Dialysate Filter | EMD Millipore Corporation | KPP | Class II | |
| K802505 | Double Lumen Tracheal Tube | National Catheter Co. Div. Mallinckrodt | BTR | Class II | |
| K801054 | Thrombo-Test (X) | Medtro GmbH | JPK | Class II | |
| K810440 | Silicone Elbow, Bed and Chair Pads | Fred Sammons, Inc. | KIC | Class I | |
| K810571 | Neocare Oxygen Monitor | Vickers America Medical Corp. | CCL | Class II | |
| K810547 | Blsi Ventilation Monitor | Bunnell Life Systems, Inc. | CAP | Class II | |
| K810544 | Incontinent Pad & Belt | Principle Business Ent. | EYQ | Class I | |
| K810537 | Automatic Screening Audiometer | Positron | EWO | Class II | |
| K810534 | Gemeni Quick-Mb Separation Kit | Gemini, Inc. | JHT | Class II | |
| K810533 | Circle Nephrostomy Tube Introducer | American V. Mueller | KOA | Class I | |
| K810504 | Therachem Anti Convulsanta Theophylline | Fisher Scientific Company L.L.C. | DIF | Class I | |
| K810497 | Bone Fixaction Screw | Serrano Intl. | HWC | Class II | |
| K810484 | Ovary Forceps | American V. Mueller | KNA | Class II | |
| K810483 | Fallopian Tube Forceps | American V. Mueller | KNA | Class II | |
| K810481 | Visual Pattern Reversal Gen. & Photic S. | Amplaid USA, Inc. | GWE | Class II | |
| K810477 | Dca Digox-Syn Ria Test | Diagnostic Corp. of America | DOG | Class II | |
| K810462 | Phadezym Rast Test | Pharmacia, Inc. | DHB | Class II | |
| K810461 | Burron Central Vein Catherization Kit | Burron Medical Products, Inc. | DQY | Class II | |
| K810460 | Burron Percutaneous Inducer Set | Burron Medical Products, Inc. | DQY | Class II | |
| K810431 | Narco Tlecare Miniature Pressure Dome | Narco Bio-Systems | DRS | Class II | |
| K810406 | Sterile Wet Dressing Pack | W.G. Whitney Corp. | |||
| K810404 | Rheumatoid Factors Reference Serum | Calbiochem-Behring Corp. | DHR | Class II | |
| K810364 | Digital Radiography System | Philips North America LLC | JAA | Class II | |
| K810360 | Baim Tm Coronary Sinus Flow Thermal | Electro-Catheter Corp. | DQO | Class II | |
| K810357 | Stress Test System | Nihon Kohden America Inc | DPS | Class II | |
| K810326 | Porocoat Tm Townley Anatomic Knee | Depuy, Inc. | JWH | Class II | |
| K810309 | Rubella Antibodies Test Reagents | Calbiochem-Behring Corp. | GOL | Class II | |
| K810307 | Zonograph 6 | Siemens Corp. | IZF | Class II | |
| K810306 | Rheumatoid Factor Reagent Test Kit | Beckman Instruments, Inc. | DHR | Class II | |
| K810284 | Automatic Teflon Injection Syringe | R. Wolf Medical Instruments Corp. | KCP | Class I | |
| K810277 | Pregelled Dispos. Electrosurg. Ground El | Conmedcorp | GEI | Class II | |
| K810276 | Alpha I and Alpha II | Porta Ray, Inc. | IZL | Class II | |
| K810274 | Clinix-R Tomographic Device | Philips North America LLC | IZF | Class II | |
| K810262 | Automatic Electrode Placement Belt | Wallant Intl. Trade, Inc. | GXY | Class II | |
| K810251 | Syringe, ENT | Megaplast, Inc. | KYZ | Class I | |
| K810067 | 140 Neocare Air Controlled Incubator | Vickers America Medical Corp. | FMZ | Class II |