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 |
|---|---|---|---|---|---|
| K944395 | Elcat D-Ppg, Plethysmograph Device | Dermatology Assoc. | JOM | Class II | |
| K944120 | Fi02 Sensing Module | Core-M, Inc. | CCL | Class II | |
| K943356 | Inclusive Endoscope | Danek Medical, Inc. | HRX | Class II | |
| K943283 | Heparin Management Test Card; Hmt Card | Cardiovascular Diagnostics, Inc. | KFF | Class II | |
| K942791 | Argyle Aqua-Seal Continuous Autotransfusion Chest Drainage Unit | Sherwood Medical Co. | CAC | Class II | |
| K942653 | Holter Ssr Digicorder(tm) | Del Mar Avionics | DSH | Class II | |
| K942586 | Cardiac Event Recorder (Instant Memory 2000) | Telescan Medical Systems | DXH | Class II | |
| K942072 | Mabis Brand and Mabis Customers Private Label Brand | Mabis Healthcare, Inc. | DXN | Class II | |
| K941845 | Buse Staff Protection Gowns and Kits | Busse Hospital Disposables | FYC | Class II | |
| K941215 | Venomidicard Infant/ Pediatric Venous Cardiotomy Reservoir | Sorin Biomedical, Inc. | DTN | Class II | |
| K934321 | Linvatec Stasys-Pes Fixation Device | Linvatec Corporation | HWC | Class II | |
| K932075 | Masterstim 1-4 | Health Care Assoc. | IPF | Class II | |
| K951701 | Fms Arthro-Cutter | Future Medical Systems, Inc. | HNX | Class I | |
| K951660 | Dynarex Gauze Sponge | Dynarex Corp. | EFQ | Unclassified | |
| K951641 | Neuroscreen Software for Use with the Neurosign 100 Nerve Monitor | Magstim Inc. | ETN | Class II | |
| K951535 | Karl Storz Endoscopes, Telescope Holders | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K951424 | M. E. R. Surgical Co. Omin Instrument System | M.E.R. Surgical Co. | EOX | Class II | |
| K951395 | Karl Storz ENT Needles, Tonsil Syringes & Needles | Karl Storz Endoscopy-America, Inc. | EOX | Class II | |
| K951161 | Mc Acclaim Q6000 Bed | Janco Consulting Services | FNL | Class II | |
| K950959 | Trocar Suprapubic, Non-Disposable Trocar, Disposable | Miller Instrument, Inc. | GCJ | Class II | |
| K950705 | 1.2Mm Disposable Neuroview Preformed Endoscope | Neuro Navigational Corp. | HRX | Class II | |
| K950698 | Lsu 2000 Portable Suction Unit | Laerdal Medical a/S | JCX | Class II | |
| K950567 | Bio-Apatite 6140 Ha Particles | Bio-Interfaces, Inc. | LYC | Class II | |
| K950562 | Implantable Staple | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | |
| K950495 | Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000 | Surgical Dynamics Ltd | BTA | Class II | |
| K950315 | Cordis Csf Reservoir | Cordis US Corp. | LKG | Class II | |
| K950238 | Gental Pulse | Parkell, Inc. | EAT | Class II | |
| K946151 | Benchmark Series Arthrosccopic Instruments | Depuy, Inc. | HRX | Class II | |
| K945230 | Arrow Kink Resistant Flexi-Cath Intra-Aortic Balloon | Arrow Intl., Inc. | DSP | Class II | |
| K951630 | Auraflex Progesterone 150Test Pack | bioMerieux, Inc. | JLS | Class I | |
| K951154 | Cedia Dau Amphetamines Assay | Microgenics Corporation | DKZ | Class II | |
| K950958 | Synchon Cx Delta Clin Syst (Cx4, Cx5, Cx7 Delta) | Beckman Instruments, Inc. | JJE | Class I | |
| K950492 | Atraumax Surgical Clamp | Applied Medical Resources Corp | DXC | Class II | |
| K946354 | Dma Unsaturated Iron Binding Capacity Procedure | Data Medical Associates, Inc. | JMO | Class I | |
| K945946 | Osteomark(r) | Ostex Intl., Inc. | JMM | Class I | |
| K945908 | Glucose (Hk) Reagent (Procedure No.16) | Sigma Diagnostics, Inc. | CFR | Class II | |
| K945541 | Schiotz Tonometer Spec. 5 Straight, Inclined, 3Inclined Scale | Rudolf Riester GmbH & Co. KG | HKY | Class II | |
| K944909 | Wahl Fresh Face | Wahl Clipper Corp | IRO | Class I | |
| K950683 | Arthrogram Tray | Surgical Technologies, Inc. | JAA | Class II | |
| K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | EBZ | Class II | |
| K951392 | Miniboneplate System | Ace Surgical Supply Co., Inc. | JEY | Class II | |
| K951361 | Dca 2000 System for Hemoglobin A1c | Kulzer GmbH | LCP | Class II | |
| K951302 | Small Fragment Plates and Screws | Medpac | JDS | Class II | |
| K951122 | Capitol Urine Drug Screen Collection Kit | Harry A. Schlakman | KDW | Class I | |
| K950893 | Kis-V Pre-Angulated and Wide Body Abutments | Implant Center of the Palm Beaches | DZE | Class II | |
| K950626 | Opticlone Cd3/cd4 Monoclonal Antibodies | IMMUNOTECH s.r.o. | GKZ | Class II | |
| K950457 | Cannual and Trocar, Superpubic | Core Dynamics, Inc. | HET | Class II | |
| K950432 | Vacutainer Brand Safety-Lok Needle Holder | BD Becton Dickinson Vacutainer Systems Preanalytic | JKA | Class II | |
| K950346 | B-L Red(tm) Discs | Oxis Intl., Inc. | JTO | Class I | |
| K950056 | The Grieshaber Axial Cutter | Grieshaber & Co. | HKP | Class II |