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 |
|---|---|---|---|---|---|
| K904268 | Accuprobe Streptococcus Pyogenes Culture Confirm. | Hologic, Inc. | MDK | Class I | |
| K904182 | R-800-Sf | Advantech Corporation | ITY | Class I | |
| K904175 | Raichem (Tm) Spia (Tm) - Acid Glycoprotein Reagent | Reagents Applications, Inc. | LKL | Class I | |
| K904041 | Haemonetics Cell Saver 4 Plus | Haemonetics Corporation | CAC | Class II | |
| K903661 | Bruker R-28,Head and Chest Angiography Imaging Add | Bruker Medical Imaging, Inc. | LNH | Class II | |
| K903589 | Ef Synergy Quad | Remel Inc | JWY | Class II | |
| K903545 | Carekits(tm), Iv/cath/cent Line Dress/tpn/cvp Kits | J.J. Skinner, Inc. | FOZ | Class II | |
| K903517 | Aib-1120 Analog-Implant Body | Minimatic Implant Technology | DZE | Class II | |
| K903516 | Bo-1121 Ball Overdenture Attachment | Minimatic Implant Technology | DZE | Class II | |
| K903115 | Dg-1109 Depth Gage | Minimatic Implant Technology | DZE | Class II | |
| K903114 | Pp-1105 Parallel Pin | Minimatic Implant Technology | DZE | Class II | |
| K903112 | Part Number: Ta-1118 Tap | Minimatic Implant Technology | DZE | Class II | |
| K903062 | Hs-1113 Healing Screw - Rev. a | Minimatic Implant Technology | DZE | Class II | |
| K903042 | Aa-1110 Analog Abutment | Minimatic Implant Technology | DZE | Class II | |
| K902982 | G.e. Polarix II C-Arm | Electromek Diagnostic Systems, Inc. | JAA | Class II | |
| K902931 | Device Part Number: Pd-12 Pilot Drill | Minimatic Implant Technology | DZE | Class II | |
| K902929 | Device Part Number Svd2, 3, 4 Spade Drill | Minimatic Implant Technology | DZE | Class II | |
| K902810 | Sterile i.v. Start Kit | Orion Life Systems, Inc. | FPA | Class II | |
| K902703 | Craniotome Blade or Drill Bit | A. Henniss | HBE | Class II | |
| K902325 | Dental Cleaning Rings | H. Bernath & Assoc. | JES | Class I | |
| K901337 | Hilal Embolization Microcoil(tm) | Cook Inc. | HCG | Class II | |
| K900986 | Thermafil Endodontic Obturator | Tulsa Dental Products LLC | EKM | Class I | |
| K904768 | Kodatrol I and II Control and Diluent Set | Eastman Kodak Company | JJY | Class I | |
| K904753 | Diolase | Scanditronix, Inc. | IWE | Class I | |
| K904301 | Du Pont Dimension(r) Salicylate(sal) Method | E.I. Dupont de Nemours & Co., Inc. | DKJ | Class II | |
| K904228 | Osseodent Dental Attachments (Non-Angled) | Collagen Corp. | DZE | Class II | |
| K904128 | Performed Template W/fragrance for Tooth Postioner | American Orthodontics | KMY | Class I | |
| K904097 | Photac-Bond Aplicap | Espe GmbH (US) | EJK | Class II | |
| K904092 | Lancer Original, Sierra, General Purpose | Lancer Orthodontics, Inc. | EJF | Class I | |
| K904035 | Rep Ultra Hdl,vldl/ldl Cholesterol System | Helena Laboratories, Corp. | LBT | Class I | |
| K904024 | Cemper | Scientific Pharmaceuticals, Inc. | EMA | Class II | |
| K903907 | Proceram Porcelain | Nobelpharma USA, Inc. | ELL | Class II | |
| K903745 | The Hayek Oscillator | Flexco Medical Instruments | BYT | Class II | |
| K903718 | Oroscope Model Number Cos-100 | Cygnus Instruments, Inc. | EHZ | Class I | |
| K903710 | Washington Cardiac Monitor | Washington Biolab, Inc. | DXK | Class II | |
| K903641 | Quick Prime Hemoconcen. No. Hq-7000 and Cbp-7000Q | Bentley Laboratories, Inc. | KDI | Class II | |
| K903635 | Perfecta Total Hip System | Orthomet, Inc. | JDI | Class II | |
| K903474 | Best Labs Model C | Best Labs | ESD | Class I | |
| K903473 | Best Labs Model S | Best Labs | ESD | Class I | |
| K903472 | Best Labs Model M | Best Labs | ESD | Class I | |
| K903471 | Best Labs Model P | Best Labs | ESD | Class I | |
| K903058 | Bact-Hme (Tm) | Pharma Systems AB | BYD | Class I | |
| K903055 | Extended Life Circuits | Pharma Systems AB | BZO | Class I | |
| K900634 | Swede-Vent Endosseous Ha Coated Dental Implants | Core-Vent Corp. | DZE | Class II | |
| K900182 | Swede-Vent Endosseous Implant Abutments | Core-Vent Corp. | DZE | Class II | |
| K904936 | Patient Examination Gloves | Slim River Latex Sdn. Bhd. | LYY | Class I | |
| K904341 | Aptt Reagent | Sigma Chemical Co. | GFO | Class II | |
| K904121 | Vialon Obturator | Deseret Medical, Inc. | FOZ | Class II | |
| K903221 | Laserdish Silicone Ventricular Lead W/trailing Tin | Telectronics Pacing Systems, Inc. | DTB | Class III | |
| K902614 | Elvi 828 Digiclot Multiscan | Logos Scientific, Inc. | KQG | Class II |