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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K823837 | Rmc Total Knee System | Richard'S Medical Equip., Inc. | MBV | Class II | |
| K823788 | Mecon I | Mecon Labs | ESD | Class I | |
| K823413 | Mouth Care Kit W/toothbrush | Sage Products LLC | |||
| K830322 | C.a.t. Reagent Kit | Remel Co. | JTQ | Class I | |
| K823925 | Cart | Medical Assoc. Intl., Inc. | |||
| K823921 | Physicians Choice Silicone Ear Putty | Santa Barbara Medco, Inc. | LDG | Class I | |
| K830296 | Corning 102 Printer | Corning Medical & Scientific | JQP | Class I | |
| K830289 | Pdb II | J.A. Gerber Therapeutical, Ltd. | INQ | Class I | |
| K830280 | Phadezym B2 Micro Test 100 | Pharmacia, Inc. | |||
| K830196 | Corstren Compression Tube & Plate | Zimmer GmbH | KTT | Class II | |
| K837100 | Digitizing Colorizing Apple Computer System for Re-View of Normal Roentgen Film | Dr. John D. Reid B.A., D.C. | |||
| K830675 | Oral Sponge | Unisplint Corp. | GEO | Class I | |
| K830654 | Infusion Pump Retrograde Exten. as 715 | Narco Scientific | FPA | Class II | |
| K830652 | Anti N DNA-Hcp | Immuno-Products Industries | KTL | Class II | |
| K830637 | Vertex Digital Substration Kit | Professional Medical Services | DQO | Class II | |
| K830627 | Clarifier-Richard-Allan | Richard-Allan Medical Ind., Inc. | KEM | Class I | |
| K830625 | Cyto-Stain | Richard-Allan Medical Ind., Inc. | HJQ | Class I | |
| K830611 | Ra Screening Test | Tago, Inc. | DHR | Class II | |
| K830609 | Inflation Device | Interventional Medical, Inc. | DXT | Class II | |
| K830608 | Usci Gruntzig Dilaca Balloon Dilation | C.R. Bard Inc | LIT | Class II | |
| K830606 | Quik-Sep Igm Isolation System | Isolab, Inc. | DFT | Class II | |
| K830602 | Precision Cap Straps | Precision Cap Systems | GXY | Class II | |
| K830601 | Foamies Diapos. Foam Rubber Pads | Precision Cap Systems | GXY | Class II | |
| K830600 | Reference & Monitoring Electrode | Precision Cap Systems | GXY | Class II | |
| K830599 | Localizing Electrode | Precision Cap Systems | GXY | Class II | |
| K830598 | Evoked Potential Cap W/evoked Potential | Precision Cap Systems | GXY | Class II | |
| K830597 | Baby Cap, Electrode Set & Board Adaptor | Precision Cap Systems | GXY | Class II | |
| K830594 | Titan Immuno-Fix | Helena Laboratories, Corp. | DEW | Class II | |
| K830591 | Corning Ferritin 125I Radioimmunoassay | Corning Medical & Scientific | DBF | Class II | |
| K830586 | Tri-Dils-Triple Olive-Esophageal Dilator | Keymed, Inc. | KNQ | Class II | |
| K830578 | Microhematocrit Reader | Fisher Scientific Company L.L.C. | JPI | Class II | |
| K830571 | Bottle Adapter | Burron Medical Products, Inc. | KYX | Class I | |
| K830570 | Personal Medication Infuser | Pacesetter Systems | FRN | Class II | |
| K830561 | Disposable Temp. Probe & Cable Models | Yellow Springs Instrument Co., Inc. | FLL | Class II | |
| K830556 | Creatinine | Horiba Instruments Incorporated | CGX | Class II | |
| K830555 | Amresco Urea Nitrogen Reagent Set | Amresco, Inc. | CDQ | Class II | |
| K830538 | Flow-Pac Total Protein Reagent Set | Amresco, Inc. | CEK | Class II | |
| K830537 | Flow-Pac Creatinine Reagent Set | Amresco, Inc. | CGX | Class II | |
| K830536 | Flow-Pac Albumin Reagent | Amresco, Inc. | CIX | Class II | |
| K830535 | Flow-Pac Alkaline Phosphate Reagent Set | Amresco, Inc. | CJF | Class II | |
| K830529 | Biofeedback-Training Instrument | Relaxomat, Inc. | HCC | Class II | |
| K830524 | Henke Ject Pressure Syringe | Smith & Nephew, Mpl Division | EJI | Class II | |
| K830521 | Precision EEG Cap W/electrode Set and | Precision Cap Systems | GXY | Class II | |
| K830502 | Nova 8 Ionized Calcium/ph Analyzer | Nova Biomedical Corporation | JFP | Class II | |
| K830484 | Omed Ident-I-Band | Omega-Med Intl., Inc. | |||
| K830482 | Abuscreen Radioimmunoassay-Amphetamine | Hoffmann-La Roche, Inc. | DJP | Class II | |
| K830481 | Abuscreen Radioimmunoassay-Phencyclidine | Hoffmann-La Roche, Inc. | LCL | Unclassified | |
| K830480 | Abuscreen Radioimmunoassay-Cocaine Meta | Hoffmann-La Roche, Inc. | KLN | Class II | |
| K830471 | Kelly-Wick Tanneler | Intl. Medical Prosthetics Research | DWS | Class I | |
| K830470 | Anesthesia Breathing Circuits | Mon-A-Therm, Inc. | CAI | Class I |