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 |
|---|---|---|---|---|---|
| K910017 | Q4500 Stree Test Monitor | Quinton, Inc. | DPS | Class II | |
| K904619 | Infu.disk | Electrochemical Drug Delivery, Inc. | FRN | Class II | |
| K896378 | Lyme-Check(tm) Test Kit | Diagnostic Technology, Inc. | LSR | Class II | |
| K913516 | Model 520A Novametrix Pulse Oximeter | Novametrix Medical Systems, Inc. | DQA | Class II | |
| K912630 | Xknife Radiosurgery System | Rsa, Inc. | IYE | Class II | |
| K914509 | Abuscreen(r) Online(tm) for Benzodiazepines | Roche Diagnostic Systems, Inc. | JXM | Class II | |
| K914348 | Er-1000 Catherization C-Arm Systems | Shimadzu Medical Systems | IYB | Class I | |
| K914019 | Mrp-5000 Hs/mr Quadrature Body Coil(p/n Mr-Qbc-31) | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K913999 | Nezhat Dorsey Suction Probe W/inner Irriga Tube | American Surgical Instruments Corp. | GCJ | Class II | |
| K913950 | Duo-Flux(r) Ultra High Perform Artificial Kidney | Althin Medical AB an Affiliate of Baxter Intl | KDI | Class II | |
| K913911 | Abuscreen(r) Radioimmunoassay for Methamphe/amphet | Roche Diagnostic Systems, Inc. | DPJ | Class II | |
| K913881 | Endostat Electrosurgical Unit | Medical and Scientific Enterprises, Inc. | KNS | Class II | |
| K913620 | Enema Kit | York County Blind Center | FCE | Class I | |
| K913578 | Milestone Ms 525 Radiographic X-Ray Generator | Control-X, Inc. | IZO | Class I | |
| K913568 | Surgi-Spray o.r. Irrigation System | Phoenix Surgical Products, Inc. | FQH | Class II | |
| K913526 | Seraflo Arterial and Venous Bloodline Sets | Althin Medical AB an Affiliate of Baxter Intl | FJK | Class II | |
| K913495 | Telex Tdr-7Aa Binaural Hear Aid/wireless Fm Rec | Telex Communications, Inc. | EPF | Class II | |
| K913494 | Telex Tdr-4Aa Monaural Hear Aid/wireless Fm Rec | Telex Communications, Inc. | EPF | Class II | |
| K913369 | Micro-Aire Model 2060 | Micro Surgical Instruments Corp. | GEY | Class I | |
| K913325 | 40-140 Spin Echo Flow Compensated Pulse Sequence | Resonex, Inc. | LNH | Class II | |
| K913321 | Hologic Qdr-2000 X-Ray Bone Densitometer | Hologic, Inc. | KGI | Class II | |
| K913306 | Bone-Temno/sternum-Temno | Proact, Ltd. | LWE | Class II | |
| K913264 | Hydraview 1000 Digital Image Process/stor Device | Mallinckrodt Group, Inc. | LLZ | Class II | |
| K913136 | Laser Endoscope Disc Decompression Kits | Medical Laser, Inc. | LRO | Class II | |
| K912612 | Smoke/odor Evacuator #757 | Olsen Electrosurgical, Inc. | FYD | Class II | |
| K911865 | Nortec Connecting Tube Set | North American Sterilization & Packaging Co. | GAZ | Class II | |
| K911587 | K-Sol(tm) | Alcon Laboratories | KDN | Class II | |
| K914672 | Qr-50-E Disposable Radiotranslucent ECG Electrode | Medicotest, Inc. | DRX | Class II | |
| K914039 | Sodium Reagent Set | Sterling Diagnostics, Inc. | CEI | Class II | |
| K913451 | Hewlett-Packard Model 78720Ac Arrhythmia Monit Sys | Hewlett-Packard Co. | DSI | Class II | |
| K913397 | Mega Angiogram Kit | Mega Medical, Inc. | DQO | Class II | |
| K913317 | Mega Arthrogram Kit | Mega Medical, Inc. | FMI | Class II | |
| K913235 | Davol Implant Ports W/attach Hi Perf Groshong Cath | Davol, Inc. | FMF | Class II | |
| K912889 | Oia Strep a | Biosearch Medical Products, Inc. | GTZ | Class I | |
| K912807 | Abbott Quick Start Creatine Kinase(ck) Item #5A17 | Em Diagnostic Systems, Inc. | JFY | Class II | |
| K912748 | Binax Equate(r) Glycohemoglobin 3 Minute Test Kit | Binax, Inc. | LCP | Class II | |
| K912085 | Aclaims-Is | W-Technology | LNJ | Class II | |
| K912045 | Tmp Pressure Isolatorr, Tmp Pressure Monitor Syst | Lifestream Int'L, Inc. | DXS | Class II | |
| K911767 | Acuson V510 Transducer | Acuson Corp. | ITX | Class II | |
| K911761 | System Athena, Type 9266 Sa02, Modification | S & W Medico Teknik | DQA | Class II | |
| K911434 | Thrombonostika F1.2 | bioMerieux, Inc. | MIF | Class II | |
| K910530 | Carbon Dioxide Laser Systems W/waveguide Delivery | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K910473 | Cyto-Stat(r)/coulter Clone(r) T11-Rd1/b4-Fitc | Coulter Immunology | GKZ | Class II | |
| K901189 | Monoclonal Antibody Anti-Cd3 | Sigma Chemical Co. | GKZ | Class II | |
| K901188 | Monoclonal Antibody Anti-Cd5 | Sigma Chemical Co. | GKZ | Class II | |
| K901187 | Monoclonal Antibody Anti-Cd2 | Sigma Chemical Co. | GKZ | Class II | |
| K901186 | Monoclonal Antibody Anti-Cd19 | Sigma Chemical Co. | GKZ | Class II | |
| K914469 | Cholestech Lipid Monit Syst, Total Chol/trig Panel | Cholestech Corp. | CHH | Class I | |
| K914468 | Abuscreen(r) Online(tm) for Barbiturates | Roche Diagnostic Systems, Inc. | DKN | Class II | |
| K914377 | Trocar | O.R. Concepts, Inc. | GCJ | Class II |