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 |
|---|---|---|---|---|---|
| K020414 | Quanta Lite Ccp Elisa | Inova Diagnostics, Inc. | NHX | Class II | |
| K020311 | Clearview Wrist Fixator | Rigid FX Orthopedics, Incorporated | KTT | Class II | |
| K020208 | Glucometer Elite Diabetes Care System (Modified) | Bayer Group Diagnostics | NBW | Class II | |
| K013471 | Delta 2000 Series Extracorporeal Lithotripter | E.S.W.L. Products, Inc. | LNS | Class II | |
| K012556 | Reprocessed Guidewires | Sterilmed Inc | NML | Class II | |
| K021197 | Sureone Insulin Syringe, 31 Gauge X 5/16 | Hosuk Co., Ltd. | FMF | Class II | |
| K021123 | Bact/alert Sn Culture Bottle | bioMerieux, Inc. | MDB | Class I | |
| K021015 | Acist Plus 4 Angiographic Catheter | Acist Medical Systems, Inc. | DQO | Class II | |
| K020989 | Super Eon Plus Femoral Stems | Howmedica Osteonics Corp | JDI | Class II | |
| K020901 | Serralsilk | Serral, S.A. de C.V. | GAP | Class II | |
| K020705 | Siis#1 Tissue Suspension System | T.A.G. Medical Products Corporation Ltd | OTN | Class II | |
| K020690 | Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens | Ocu-Ease Optical Products, Inc. | LPL | Class II | |
| K020626 | Microscan Microstrep Plus Panel New Antimicrobial-Penicillin | Dade Microscan, Inc. | LTT | Class II | |
| K020578 | Gc Fuji Ortho Band Paste Pak | GC America Inc. | DYH | Class II | |
| K020556 | Microscan Microstrep Plus Panel with Levofloxacin | Dade Microscan, Inc. | JWY | Class II | |
| K020546 | Fusion 7D | Mirada Solutions, Ltd. | LLZ | Class II | |
| K020392 | Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear | CooperVision, Inc. | LPL | Class II | |
| K020307 | Lap Disc 120 X 120Mm X 2Cm #Ld111; Lap Disc 120 X 120Mm X 7Cm #Ld112 | Hakko Shoji Co., Ltd. | GCJ | Class II | |
| K020272 | Male Latex Condom with Ribbed Surface | Pleasure Latex Products Sdn. Bhd. | HIS | Class II | |
| K013776 | Microjet Model # Cd4 and Cd4/20 | Cane S.R.I. | FRN | Class II | |
| K013234 | Microjet Crono | Cane S.r.l. | FRN | Class II | |
| K012214 | Cryopen and Accessories | Cimex Biotech, LLC | GEH | Class II | |
| K021027 | S2 Tibial Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K021026 | S2 Femoral Nail | Howmedica Osteonics Corp | HSB | Class II | |
| K021005 | Simplicity Easy Access II Infusion Set for Infusion And/or Injection of Fluids into the Body Below the Surface | Sterling Medivations, Inc. | FPA | Class II | |
| K020708 | Philips Pagewriter Touch Cardiograph, Model M5000a Series | Philips North America LLC | DPS | Class II | |
| K020333 | Atrion Medical Ql Fluid Dispensing Syringe | Atrion Medical Products, Inc. | DXT | Class II | |
| K020268 | Isaac 1.5 T Mr System | Chi, Inc. | LNH | Class II | |
| K014168 | Au6 (Technos/technos Mp) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication) | Esaote North America, Inc | IYN | Class II | |
| K014089 | Visualine II (Also Known as Sunline) Bariturates | Sun Biomedical Laboratories, Inc. | DIS | Class II | |
| K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic, Inc. | DQY | Class II | |
| K013310 | Pvs Basic 2; Epic 2 | Paragon Vision Sciences, Inc. | HQD | Class II | |
| K010128 | Cook Vascular Peel-Away Hemostasis Valve | Cook Vandergrift, Inc. | DYB | Class II | |
| K021103 | Modification to Zeus Scientific's Athena Multi-Lyte Ana Test System | Zeus Scientific LLC | LKJ | Class II | |
| K020954 | H/s Procedure Tray (5F), H/s Procedure Tray (7F), H/s Elliptosphere Procedure Tray & Multipurpose Procedure Tray | Ackrad Laboratories | LKF | Class II | |
| K020601 | Flexicoil - Malleable Receive-Only Surface Coil | Medtronic Navigation, Inc | MOS | Class II | |
| K020570 | Simplicity | Apex Dental Materials, Inc. | KLE | Class II | |
| K020532 | Polymedco Hba1c Test | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC | LCP | Class II | |
| K020515 | Jostra Antegrade Cardioplegia Cannula | Jostra AG | DWF | Class II | |
| K020347 | Agc Speziallegierung | Wieland Edelmetalle GmbH & Co. | EJT | Class II | |
| K020289 | Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias | Machnet BV | LNH | Class II | |
| K020257 | Datascope's 8Fr. Alt B Iab; Datascope's Profile 8Fr. Alt B Iab; Datascope's True Sheathless Dl 9.5 Fr. Iab; Datascope's | Datascope Corp. | DSP | Class II | |
| K003896 | Lympha Vision-Expert | Bexley Trading, Inc. | GXY | Class II | |
| K021051 | Annuloflo System, Mitral Model Ar700 | Sulzer Carbomedics, Inc. | KRH | Class II | |
| K020838 | Ultra Touch Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less) | Ar Alliance Healthcare Sdn. Bhd. | LYY | Class I | |
| K020604 | Warmtouch Patient Warming System, Model 5300 | Medtronic, Inc. | DWJ | Class II | |
| K020505 | Synthes Translating Maxillary Distractor | Synthes (USA) Products LLC | JEY | Class II | |
| K020495 | Intercept Esophageal Internal Mr Coil, Intercept Urethral Internal Mr Coil, and Intercept Vascular Internal Mr Coil | Surgi-Vision, Inc. | MOS | Class II | |
| K020300 | Northwestern Gated Blood Pool Spect (Numugas) | Syntermed, Inc. | KPS | Class II | |
| K020230 | Diasol-Bicarb | Diasol, Inc | KPO | Class II |