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 |
|---|---|---|---|---|---|
| K830706 | E.t. Strap #6000 | Rnd Medical Products, Inc. | CBH | Class I | |
| K830703 | Glomark | Alphamedix, Inc. | FZZ | Class I | |
| K830663 | Pencil Skin Abrader | Ndm Corp. | DRX | Class II | |
| K830595 | Monitral | Hospal Medical Corp. | KDI | Class II | |
| K830487 | Hemo-Processing System | Sartorius Filters, Inc. | KDI | Class II | |
| K830440 | Denta Plast | Denta, Inc. | EMA | Class II | |
| K830426 | Inflatable Invalid Ring | Maddak, Inc. | KIC | Class I | |
| K830415 | Diagnostic Intravascular Catheter | Mallinckrodt Critical Care | DQO | Class II | |
| K828562 | Digirad CFR 2000 Radiographic Film Cassette | Digirad Corp. | |||
| K823790 | Ventricular Access System | American Heyer Schulte | LKG | Class II | |
| K823757 | Surgitek Endotracheal Tube, Laser Resis | Medical Engineering Corp. | BTR | Class II | |
| K823206 | Martin Pelvic Lift | Martin Pelvic Lift Co. | FSA | Class I | |
| K822617 | Vpd540 Defibrillator | Life Science Instrumentation, Inc. | LDD | Class II | |
| K831103 | Tia-Igm Reagent & Calibrator Sets | Worthington Diagnostic Systems | DFT | Class II | |
| K831102 | Tia-Iga Reagent & Calibrator Sets | Worthington Diagnostic Systems | CZP | Class II | |
| K831101 | Tia-Igg Reagent & Calibrator Sets | Worthington Diagnostic Systems | DEW | Class II | |
| K831091 | New Allergen Disc -Vast Ventex Allergy | Ventrex Laboratories, Inc. | DHB | Class II | |
| K831054 | Antinuclear Antibody Tissue Culture Sub | Immuno-Products Industries | DHN | Class II | |
| K831045 | Phadebas & Phadezym Rast Mixed Allerg | Pharmacia, Inc. | DHB | Class II | |
| K831036 | Ena Test Kit Sm & Rnp Auto Antibody | Calbiochem-Behring Corp. | LLL | Class II | |
| K831033 | Girex | Lancer Assoc. | ION | Class I | |
| K830972 | i.v. Catheter Placement Unit Polyureth | Critikon Company, LLC | FOZ | Class II | |
| K830956 | Netilmicin 30Mcg. Sensitivity Discs | Difco Laboratories, Inc. | JTN | Class II | |
| K830918 | I.e.c Column | Berwick Medical Products, Inc. | KEA | Class I | |
| K830893 | Acth Ria System-Dsi 2300 | Diagnostic Systems Laboratories, Inc. | CKG | Class II | |
| K830890 | Surgical Face Mask | Busse Hospital Disposables | FXX | Class II | |
| K830888 | Cool-Lite Fibercoptic Laryngeal Exam | National Medical Technology | EQN | Class II | |
| K830821 | Micro-Mitt | CooperVision, Inc. | FXP | Class I | |
| K830817 | New Allergen Discs for Use in Vast Vent | Ventrex Laboratories, Inc. | DGC | Class II | |
| K830725 | Gent-L-Spec Dispos. Vaginal Speculum | Geneva Laboratories, Inc. | HIB | Class II | |
| K830596 | Ultrafiltration Monitor Ufm-10-2 | Gambro, Inc. | KDI | Class II | |
| K830589 | Electrolyte Standard - Corning Nalk Ise | Shaban Mfg. Co. | JGS | Class II | |
| K830588 | Potassium Analyzer-Sodium/electrolyte | Shaban Mfg. Co. | JGS | Class II | |
| K830532 | Electrosurgical Caultery Pencil | American V. Mueller | GEI | Class II | |
| K830451 | Qbc Centrifugal Hematology Sys | BD Becton Dickinson Vacutainer Systems Preanalytic | GKL | Class II | |
| K830445 | Phadebact Strep F Test | Pharmacia, Inc. | GTZ | Class I | |
| K830411 | Miniscope Ms-2 | JEDMED Instrument Company | DSP | Class II | |
| K830410 | Ek Combi Msg-1 | JEDMED Instrument Company | DSP | Class II | |
| K823588 | Personal Romear | Romear Mfg., Inc. | ESD | Class I | |
| K837282 | Model Vps Vascular Profile System | Hoffrel Instruments, Inc. | |||
| K831046 | Electrode 3799 | Medtronic, Inc. | GXY | Class II | |
| K830121 | Insall/burstein Fiber Metal Condylar/kne | Zimmer GmbH | JWH | Class II | |
| K837334 | X-Ray Beam Filter | Eastman Kodak Company | |||
| K837354 | Powered Mobile Base for 200Mm and 300Mm Size Detectors | General Electric Co. | |||
| K837351 | Exoscope Ls-53 | Elscint, Inc. | |||
| K837322 | Novo Cerebrograph | Novo Diagnostic Systems | |||
| K837306 | Laser Photocoagulator | Hgm, Inc. | |||
| K837278 | Uwe Sun Stream Uwe Bermuda Uwe Super Nova and Uwe Bronzarette | Unterwasser-Electric GmbH | |||
| K830004 | Porocoat Dual-Lock Total Hip System | Depuy, Inc. | JDI | Class II | |
| K830965 | Enteral Solution Admin. Pump Set | Corpak Co. | KNT | Class II |