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 |
|---|---|---|---|---|---|
| K980550 | Whistle Watch | Harwill Medical (Pty), Ltd. | BZH | Class II | |
| K974090 | 95 C/1.5 Citric Acid Heat Processing of Polysulfone Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | MSE | Class II | |
| K973943 | Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments for Endoscopic Subfascial Discision of per | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K972689 | Caow Hemostasis System | Anlam Corp. | DXC | Class II | |
| K982707 | Ec6 Plethysmograph | D. E. Hokanson, Inc. | JOM | Class II | |
| K982378 | Hemsol-Acid Concentrate Liquid Hemogran Acid Concentrate Powder, Nephrosol-Acetate Concentrate Powder, Bicarbosol-Bicare | Solution Technologies | KPO | Class II | |
| K982265 | Aquilion CT Scanner, Model Tsx-101A | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K981897 | Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae | Roche Diagnostic Systems, Inc. | CJE | Class II | |
| K981329 | Feth-R-Kath | Epimed International, Inc. | BSO | Class II | |
| K980468 | Au5 Ultrasound Imaging System | Esaote North America, Inc | IYN | Class II | |
| K982880 | Dimension(r) Valproic (Valp) Acid Method | Siemens Healthcare Diagnostics Inc. | LEG | Class II | |
| K982442 | C-Trak Automatic Analyzer (Name Change from Oncoprobe II to C-Trak) | Care Wise Medical Products Corp. | IZD | Class I | |
| K982429 | Zstatflu Test for Influenza Types a and B Viruses | Zymetx, Inc. | PSZ | Class II | |
| K982061 | Stc Cocaine Metabolite Micro-Plate Eia (Orasure Device) | OraSure Technologies, Inc. | DIO | Class II | |
| K981989 | The Wave Digital Phaco System | Circuit Tree | HQC | Class II | |
| K981931 | Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay | Roche Diagnostics/Boehringer Mannheim GmbH | CGN | Class II | |
| K981801 | Accusign Tca, Biosign Tca, Staus Ds Tca | Princeton BioMeditech Corp. | LFH | Class II | |
| K981742 | One Up Disposable Keratome Head | Moria SA | HNO | Class I | |
| K974220 | Micromedical 12 Lead Simultaneous Cable | Micromedical, Inc. | DPS | Class II | |
| K973751 | Mt-200 | Schiller America, Inc. | DQK | Class II | |
| K973735 | Microvit Mt-100 | Schiller America, Inc. | DSH | Class II | |
| K973593 | Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry Administration Set 5 | Bridge Medical, Inc. | FRN | Class II | |
| K982730 | Sc 7000 & Sc 9000 Xl Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K982615 | Airdent Radiance Curing Light | Air Techniques, Inc. | EBZ | Class II | |
| K982587 | Mps Fixed Flow Rate Set | Medical Product Specialists | FPA | Class II | |
| K982537 | Tokuyama Sofreliner | Tokuyama America Inc. | EBI | Class II | |
| K982461 | Glasionomer Cement Cx Plus | Shofu Dental Corp. | EMA | Class II | |
| K982460 | Vivacap Hr | Ab Ardent | EJJ | Class II | |
| K982458 | Vivalloy Hr | Ab Ardent | EJJ | Class II | |
| K982456 | Amalcap Plus | Ab Ardent | EJJ | Class II | |
| K982420 | Mitek Micro Anchor | Mitek Products | JDR | Class II | |
| K982369 | Convertors, Spunbonded, Flashspun Polyolefin Gowns | Medtronic, Inc. | FYC | Class II | |
| K982367 | Reach Hip Component | Zimmer GmbH | LPH | Class II | |
| K981971 | Tbird Vs/avs Volume Ventilator, Models 15568, 15570 , Lp10 Volume Ventilator with Pressure Limit Model 00-004130, Bear 3 | Bird Products Corp. | CBK | Class II | |
| K981944 | Breatherite | Salter Labs | CAF | Class II | |
| K981937 | Welch Allyn Reveal Intraoral Camera System | Welch Allyn Inc | EIA | Class I | |
| K981923 | The Snore Peace | The Snore Peace Group | LRK | Class II | |
| K981910 | Suction Catheter | Ni-Med, Inc. | BSY | Class I | |
| K981272 | Addiquip Disposable Acupuncture Needles | Electro Therapeutic Devices Inc | MQX | Class II | |
| K980786 | Cobe Closed Venous Reservoir Bags with Smarx T, Models Vrb 1200 and Vrb 1800 | LivaNova USA, Inc. | DTN | Class II | |
| K980725 | Exhalation Valve (Be 30-115-B, Ns 30-115-U, Ns 30-115-5, Ps 54-a) | Instrumentation Industries, Incorporated | CBP | Class II | |
| K980559 | Pegasus Nd:yag Laser System | Premier Laser Systems, Inc. | GEX | Class II | |
| K961903 | Magellan | Biosense, Ltd. | HAW | Class II | |
| K982845 | Cardiac Markers Control (Single Use)-Levels, 1,2,3, Models Number 175-1, 175-2, 175-3 | More Diagnostics Inc. | JJT | Class I | |
| K982638 | 3M Tegagen Hi Alginate Dressing & 3 M Tegagen Hg Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214 | Innovative Technologies, Ltd. | QSY | Unclassified | |
| K982628 | Medworks Insemination Catheter | Medworks Corp. | MFD | Class II | |
| K982409 | Ves 1501-M | Angiolaz, Inc. | FWF | Class I | |
| K982336 | Kuschall Design K3/k4 Series of Manual Wheelchairs | Invacare GmbH | IOR | Class I | |
| K982238 | Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522 | Binax, Inc. | MJH | Class II | |
| K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | LLZ | Class II |