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 |
|---|---|---|---|---|---|
| K982825 | Brennen Medical Beta Glucan Gel | Brennen Medical, Inc. | MGQ | Unclassified | |
| K982815 | Alphatrac, Model A200 | Teftec Corp. | ITI | Class II | |
| K982813 | Naturalyte, Model # 08-4004-1 | Kaybath, Inc. | KPO | Class II | |
| K982575 | Mesh, Surgical, Polymeric | United States Surgical, A Division of Tyco Healthc | FTL | Class II | |
| K982435 | Irrigation Syringe Kit | Sub-Q, Inc. | KYZ | Class I | |
| K982410 | Smp-Plus,sx-Plus,sx Model # 49Xx Series 9 Volt TENS Device | Rehabilicare, Inc. | GZJ | Class II | |
| K982110 | Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear | Optech, Inc. | LPL | Class II | |
| K981526 | Ace Alveolar Distractor | Ace Surgical Supply Co., Inc. | JEY | Class II | |
| K981462 | Quickie P100 Series, Quickie P200 Series, Quickie P300 Series, Models P100,p110,p120,p190,p190r,p500,p200,p210,p320,p300 | Sunrise Medical, Inc. | ITI | Class II | |
| K980999 | St Leger Cemented Semi-Constrained Total Knee Implant | Instrument Makar, Inc. | JWH | Class II | |
| K980895 | Allegro Ultrasonic Soft Tissue Aspirator | California Institute of Tissue Eng. & Instrumenti | LFL | Unclassified | |
| K973585 | Propper Eo Line Ethylene Oxide Sterilization Integrator | Propper Mfg Co Inc | JOJ | Class II | |
| K983612 | Powder-Free Non Sterile Vinyl Examination Gloves | Shanghai Jiatai Plastic Products Co., Ltd. | LYZ | Class I | |
| K983608 | Evergreen Non-Sterile, Powder-Free, Protein Content Labeling Claim Examination Gloves: Natural, Blue & Pink | Yty Industry (Manjung) Sdn. Bhd. | LYY | Class I | |
| K983494 | Vinyl Exam Gloves, Powder Free | Glormed Intl., Inc. | LYZ | Class I | |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing Electrode | Graphic Controls Corp. | MKJ | Class III | |
| K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | DKB | Class II | |
| K983151 | Immage Immunochemistry System Digoxin (Dig) Reagent | Siemens Healthcare Diagnostics Inc. | KXT | Class II | |
| K982821 | Mms Therpacplus B3dtui Model Number 6.7 | Multimedia Medical Systems, Inc. | MUJ | Class II | |
| K982720 | H-Ray | Shijiazhuang Hongray Plastic Products Co., Ltd. | LYZ | Class I | |
| K982166 | Cyto-Stat Trichrome Cd45-Fitc/cd56-Rd1/cd3-Pc5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Cd45-Fitc/msigg1-Rd1 | Coulter Corp. | GKZ | Class II | |
| K981064 | Powderfree Colored and Flavored Chloroprene Patient Examination Gloves | P.T. Irama Dinamika Latex | LZA | Class I | |
| K980756 | Corometrics Transcutaneous Tcpo2/co2 Module | GE Medical Systems Information Technologies, Inc. | LKD | Class II | |
| K980129 | Instruments for Endoscopic Plastic Surgery (Eps) | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K983857 | Autovent 1500 | O-Two Systems Intl., Inc. | BTL | Class II | |
| K983722 | Stratus Cs Troponin I Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K983693 | Dimensions (R) Rxl Cardiac Troponin I Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K983507 | Vitros Immunodiagnostic Products Testosterone Assay | Ortho-Clinical Diagnostics, Inc. | JJY | Class I | |
| K983441 | C3 | Abbott Medical | CZW | Class II | |
| K983359 | Iga | Abbott Medical | CZP | Class II | |
| K983356 | C4 | Abbott Medical | DBI | Class II | |
| K983304 | Synermed Near-Infrared Direct Bilirubin Reagent Kit | Synermed Intl., Inc. | CIG | Class II | |
| K983285 | Engle Dental Family of Delivery Systems | Engle Dental Systems, LLC | EIA | Class I | |
| K983221 | Igg | Abbott Medical | DEW | Class II | |
| K983209 | Synchron Systems Dat Low and High Urine Calibrators I | Siemens Healthcare Diagnostics Inc. | DKB | Class II | |
| K983167 | Trf | Abbott Medical | DDG | Class II | |
| K983140 | CT Biopsyview | Philips North America LLC | JAK | Class II | |
| K983132 | Igm | Abbott Medical | DFT | Class II | |
| K983084 | Quanta Lite RF Iga Elisa | Inova Diagnostics, Inc. | DHR | Class II | |
| K983083 | Quanta Lite RF Igg Elisa | Inova Diagnostics, Inc. | DHR | Class II | |
| K982955 | Silhouette Vr | GE Healthcare | KPR | Class II | |
| K982857 | Helax-Imcon, Version 1.0 | Helax AB | KPQ | Class II | |
| K982855 | Digirad 2020Tc Spect Imaging System | Digirad Corp. | KPS | Class II | |
| K982838 | Cadd-Legacy 1 Ambulatory Infusion System Model Number 6400 | Sims Deltec, Inc. | FRN | Class II | |
| K982801 | Auto-Lyte Pcp Eia, Model #1254U | OraSure Technologies, Inc. | LCM | Unclassified | |
| K982790 | Quanta Lite H. Pylori Igg Elisa | Inova Diagnostics, Inc. | LYR | Class I | |
| K982760 | Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing Set | Gambro Healthcare | KDI | Class II | |
| K982639 | Spife Urine Ife | Helena Laboratories, Corp. | DAO | Class II | |
| K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon Medical Components U.S.A., Inc. | MQB | Class II | |
| K973765 | Bio-2000 | Micrylium Laboratories Inc. | EIA | Class I |