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 |
|---|---|---|---|---|---|
| K901485 | Enzygnost Anti-Cmv/igg + Igm | Behring Diagnostics, Inc. | LFZ | Class II | |
| K911709 | Stock Canal, in-the-Ear Hearing Aid | Electone, Inc. | ESD | Class I | |
| K911708 | Model E-50, in-the-Ear Hearing Aid | Electone, Inc. | ESD | Class I | |
| K911707 | Regal, Behind-the-Ear Hearing Aid | Electone, Inc. | ESD | Class I | |
| K911706 | Model 800, Behind-the-Ear Hearing Aid | Electone, Inc. | ESD | Class I | |
| K911705 | Champion, Behind-the-Ear Hearing Aid | Electone, Inc. | ESD | Class I | |
| K911437 | Kodak Ektascan Cable Extension | Eastman Kodak Company | LMC | Class II | |
| K910949 | Latex Exam Gloves-Powder Free | Zhongmin (Fujian) Machinery & Electrical Equipment | LYY | Class I | |
| K910859 | Computerized Tomography X-Ray System | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K910791 | Curity(r) Calib Tuohy Type Epidur Needle Fix Wing | Kendall Healthcare Products Co. Div.Of Tyco Health | BSP | Class II | |
| K910694 | Zinetics Internal Reference Probe | Zinetics Medical, Inc. | FFT | Class I | |
| K910659 | Augustine Stylet | Augustine Medical, Inc. | BSR | Class I | |
| K910048 | Ecat Scanner | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K905413 | Juzo-Respira Anti-Embolism Stocking | Julius Zorn GmbH | DWL | Class II | |
| K911122 | 8Mm Quantum Pulse/suprima II Pulse Generators | Intermedics, Inc. | DXY | Class III | |
| K910969 | Torque Device for a Guide Wire | Terumo Corp. | DQX | Class II | |
| K910935 | Modified Pyrogen Testing | Electromedics, Inc. | DTM | Class II | |
| K910688 | Cordis Peel-Away Insertion Tool | Cordis US Corp. | DYB | Class II | |
| K910327 | Warmair System | Gentherm Medical, LLC | DWJ | Class II | |
| K910221 | Rmi Vascular Tourniquet Kit | Research Medical, Inc. | DXC | Class II | |
| K905824 | Maestro(r) Series 100/200 Cardiac S/chamb Pacemake | Cardiac Control Systems, Inc. | DXY | Class III | |
| K904868 | Xemex Temporary Pacing Catheter a | Zeon Medical Corp. | LDF | Class II | |
| K911941 | Cedia(r) Digoxin R' Assay | Microgenics Corporation | KXT | Class II | |
| K911803 | Hi Chem Aqueous Multianalyte Line Stand, Modified | Hichem Diagnostics | JJY | Class I | |
| K911792 | First Choice(tm), Modification | Polymer Technology Corp. | CGA | Class II | |
| K911712 | Stratus(r) Automated Sample Handler | Baxter Healthcare Corporation | JQW | Class I | |
| K911701 | G-Floss & G-Floss II | Implant Innovations International, Inc. | JES | Class I | |
| K911652 | Mircoline Screen for Cocaine | Drug Screening Systems, Inc. | DIO | Class II | |
| K911596 | Vision Bg Monitor | British-American Medical, Inc. | CGA | Class II | |
| K911578 | Cholestech L.d.x. Lipid Analyzer, Modification | Cholestech Corp. | CHH | Class I | |
| K911558 | Antimicrobial Suscept. Test Panel Nitrofurantoin | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911525 | Tokuso Light Bond | Tokuyama America Inc. | KLE | Class II | |
| K911470 | Buffing Floss | Lamar Industries | JES | Class I | |
| K911281 | Pulpdent Pic N Stic | Pulpdent Corporation | EKJ | Class I | |
| K911269 | Mercury and Glass Fever Thermometer | Steridyne Corp. | FLK | Class II | |
| K911072 | Super Evacretractor, Disposable Oral Evacuator | A & F Products | EHZ | Class I | |
| K911068 | 29540 Dynasurg Electric Handpiece and Irr. System | Micro Motors, Inc. | EFB | Class I | |
| K910920 | Protekt Gloves | Intermedics Orthopedics | FYE | Class I | |
| K910851 | Tassi Mk3 (Turnair) | Therapy Air Support Systems, Inc. | IOQ | Class II | |
| K910781 | #491 Power Otolaryngoly Ch/#498 Proced Ctr & Acces | Midmark Corp | ETF | Class I | |
| K910635 | Total Bilirubin Reagent Set | Biochemical Trade, Inc. | CIG | Class II | |
| K910617 | Native Prothrombin Antigen Eia | bioMerieux, Inc. | DDF | Class I | |
| K910371 | Urodynamic Measuring System | Browne Medical Systems, Inc. | FAP | Class II | |
| K905741 | Clearview Hcg Serum/urine | Unipath, Ltd. | JHI | Class II | |
| K905691 | Qdr-1000 and with X-Ray Bone Densitometer | Hologic, Inc. | KGI | Class II | |
| K905657 | Sonopak/qs, Sonopak | Bioresearch | NFQ | Class I | |
| K905653 | Advantx Afm Angio System S1808 | GE Healthcare | IZI | Class II | |
| K904853 | Model Stt-100 | Sonocare, Inc. | IYO | Class II | |
| K904135 | Foundation Hybrid Composite | Nulite Systems Research | EBD | Class II | |
| K902968 | Bio-Vent-X Endosseous Ha Coated Dental Implants | Core-Vent Corp. | DZE | Class II |