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 |
|---|---|---|---|---|---|
| K903877 | Mts Femoral Hip System | 3M Company | KWL | Class II | |
| K903828 | Synaps (Tm) | Henley Intl. | GZJ | Class II | |
| K903638 | Gastro-Intestinal Accu-Culshure Tm | Medical Laboratory Automation Systems, Inc. | LIO | Class I | |
| K903186 | Optima Series II Model 147B Single Chamber Pulse | Telectronics Pacing Systems, Inc. | DXY | Class III | |
| K903136 | Arzo Tapcath Esophageal Recording Catheter | Arzco Medical Electronics, Inc. | DRF | Class II | |
| K903133 | Omron Oscillometric Digital Bp Monitor-Hem-405C | Omron Marshall Products, Inc. | DXN | Class II | |
| K902782 | Series 1500 Responder | Marquette Electronics, Inc. | LDD | Class II | |
| K902159 | Biflex(tm) Annuloplasty Ring | Abbott Medical | KRH | Class II | |
| K896817 | Model T11 Fluidotherapy Unit | Henley Intl. | LSB | Class II | |
| K910086 | Abuscreen Online Cocaine Metabolite Calibrators | Roche Diagnostic Systems, Inc. | DLJ | Class II | |
| K905719 | Eclipse Ica Digoxin | Biotope, Inc. | DPO | Class II | |
| K905689 | Cedia Phenytoin Assay | Microgenics Corporation | DIP | Class II | |
| K905601 | Eclipse Ica Triglycerides | Biotope, Inc. | CDT | Class I | |
| K905588 | Creatine Kinase UV Reagent Set | Biochemical Trade, Inc. | JHW | Class II | |
| K905379 | Auto Suture Modified Surgitie Endo. Ligating Loop | United States Surgical, A Division of Tyco Healthc | GAR | Class II | |
| K905328 | Will-Ceram Brushes, Super Brush Kit | Ivoclar North America, Inc. | EIH | Class II | |
| K905247 | Shbg Irma Kit | Ventrex Laboratories, Inc. | CDZ | Class I | |
| K904816 | Thyroxine Monoclonal Antibody Solid Phase Radioimm | BD Becton Dickinson Vacutainer Systems Preanalytic | CDX | Class II | |
| K904468 | Direct Bilirubin Reagent, 7776/7777/7576/7476/7176 | Amresco, Inc. | CIG | Class II | |
| K904326 | De-Tox Tubes a and De-Tox Tubes B | Dyna-Tek Industries | DPA | Class I | |
| K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | ILX | Class II | |
| K905602 | Eclipse Ica Bun | Biotope, Inc. | CDQ | Class II | |
| K905587 | Auto Suture(r) Endoscopic Lds(tm) Ligating Device | United States Surgical, A Division of Tyco Healthc | FZP | Class II | |
| K905393 | Hc-Series Medical Camera/light Source and Accessor | Frigitronics, Inc. | FWF | Class I | |
| K905322 | Midigold 50 | Ivoclar North America, Inc. | EJT | Class II | |
| K905018 | Lab-Site Safety Needle | Telos Medical Corp. | DQO | Class II | |
| K904965 | Shampaine 1000 Series Angenieux Ax-14 Duo,ax-4 | Smith & Nephew Equipment Group | FSY | Class II | |
| K904954 | Condor Digital Inflation Syringe | Professional Medical Services | MAV | Class II | |
| K904888 | Autowand(tm) 7Xxx Series, Modification | Boehringer Laboratories, LLC | CAC | Class II | |
| K904801 | Orion Life Systems Replacement Gastrostomy Tube | Orion Life Systems, Inc. | KGC | Class II | |
| K904378 | F.t.i. Medical Light Guide | Fiberoptics Technology, Inc. | EQH | Class I | |
| K904287 | Stealth Dilation Catheter System/modification | Target Therapeutics | DYG | Class II | |
| K904282 | Bifurcated Gore Tex Stretch Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K903823 | Speedwrap, Dynawrap, Dynaplast Tape | Smith and Nephew Donjoy, Inc. | KGX | Class I | |
| K903814 | Neuromed Ts8 Test Stimulator | Neuromed, Inc. | GZB | Class II | |
| K903711 | Rheologic I | Advanced Rehabilitative Technology, Inc. | IPF | Class II | |
| K903700 | Ipg-II Module | Life Sciences Manufacturing, Inc. | DSB | Class II | |
| K902910 | Cytoaspirator | H & B Medical Technology, Inc. | FCK | Class II | |
| K902674 | Datascope Arterial Cannula W/access Port | Datascope Corp. | DQR | Class II | |
| K910047 | Patient Examination Gloves-Textured Gloves | Pan-Century Rubber Products Sdn. Bhd. | LYY | Class I | |
| K910046 | Patient Examination Gloves-Anatomical Gloves | Pan-Century Rubber Products Sdn. Bhd. | LYY | Class I | |
| K910045 | Patient Examination Gloves-Powder Freed | Pan-Century Rubber Products Sdn. Bhd. | LYY | Class I | |
| K905730 | Abuscreen Ontrak for Cocaine (200Ng/ml) | Roche Diagnostic Systems, Inc. | KLN | Class II | |
| K905700 | Ez-Screen: Amphetamines | Environmental Diagnostics, Inc. | DKZ | Class II | |
| K905665 | Patient Examination Gloves | Medical Products Search, Inc. | LYY | Class I | |
| K905659 | Systemate Calcium (Epos Application) #65409 | Em Diagnostic Systems, Inc. | CIC | Class II | |
| K905600 | Techlyte Electrolyte Analyzer | Technalysis, Inc. | JGS | Class II | |
| K905551 | Patient Examination Gloves | Johnson & Johnson MEDICAL GmbH | LYY | Class I | |
| K905532 | Ciba Corning Acs T4 Immunoassay | Ciba Corning Diagnostics Corp. | CDX | Class II | |
| K905513 | Glyc-Affin(tm)-Ga | Isolab, Inc. | LCP | Class II |