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 |
|---|---|---|---|---|---|
| K914888 | Technicon Chem 1(Tm) Syst (Gen2 Syst) | Technicon Instruments Corp. | CIX | Class II | |
| K914536 | Models 190Ge-64/191Ge-64/192Ge-64/193Ge-64 | Medical Advances, Inc. | LNH | Class II | |
| K914535 | Model 311Ge-64: Whole Volume Neck Coil | Medical Advances, Inc. | LNH | Class II | |
| K914511 | Technicon Axon(tm) System Methods Anyalye Hdl Chol | Technicon Instruments Corp. | LBS | Class I | |
| K914508 | Dimension(r) Lactic Acid Method | E.I. Dupont de Nemours & Co., Inc. | KHP | Class I | |
| K914498 | Powder Free, Non-Sterile, Latex Examination Gloves | Medmark, Inc. | LYY | Class I | |
| K914486 | Coulter Carbon Dioxide Reagent | Coulter Corp. | KHS | Class II | |
| K914426 | Entree Needle | Core Dynamics, Inc. | FHO | Class II | |
| K914403 | General Use Kit #7-510-20 | Northgate Technologies Inc. | HIF | Class II | |
| K914402 | Recirculation Kit #7-510-18 | Northgate Technologies Inc. | HIF | Class II | |
| K914401 | Universal General Use Kit #7-510-16 | Northgate Technologies Inc. | HIF | Class II | |
| K914346 | Drill Modules Models 2116/2117 | Micro Surgical Instruments Corp. | ERL | Class II | |
| K914313 | Hicor | Siemens Gammasonics, Inc. | IZI | Class II | |
| K914296 | Cequal(tm) Quanitative Analysis Cardiolite(r) Spec | Nuccardiac Software, Inc. | KPS | Class II | |
| K914266 | Micro-X 30 HF | Fischer Imaging Corp. | IZO | Class I | |
| K914236 | Micro-X 50 HF | Fischer Imaging Corp. | IZO | Class I | |
| K914212 | Bard Singular Biopsy Forceps | C.R. Bard Inc | FCL | Class I | |
| K914184 | P2020-8-0 Beam-Limiting Device | Precise Optics | KPW | Class II | |
| K914128 | Connecting Set | Procedure Products, Inc. | DQO | Class II | |
| K914116 | Plasma Tfe Synthetic Artery-Clarification | Medtronic, Inc. | DSY | Class II | |
| K914082 | Suan Flat Dissector Sponges | Icn Pharmaceuticals, Inc. | GDY | Class I | |
| K914048 | Needle*lock(tm) with Interlink(tm) Injection Site | Baxter Healthcare Corporation | FPA | Class II | |
| K914012 | Mrt-150A | Toshiba America Mri, Inc. | LNH | Class II | |
| K913979 | Endo I/a Y Set | Snowden-Pencer | HIF | Class II | |
| K913929 | Dfc-1024 & Dfc-512 Digital Imaging System | Ophthalmic Imaging Systems | HKI | Class II | |
| K913913 | Refurbished Orthodontic Appliances | Ortho-Cycle Co. | EJF | Class I | |
| K913879 | Cbc-8K(tm) Hematology Control/multiple | R & D Systems, Inc. | JPK | Class II | |
| K913875 | Bard(r) Biopotential Amplifier II | Bard Electrophysiology | DRQ | Class II | |
| K913874 | Infinity(tm) Microtaper Hip System | Dow Corning Wright | JDI | Class II | |
| K913807 | Rep(r) Spe Template 30, 16, & 8 | Helena Laboratories, Corp. | CEF | Class I | |
| K913637 | Ecat Scanner (Model 921) | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K913498 | Mx927 Blood Transfer Device | Medex, Inc. | FMI | Class II | |
| K913250 | Acs Ultra-2 Thromboplastin | Analytical Control Systems | GJS | Class II | |
| K913054 | 3M Anti-Cardiolipin Fast(tm) Test | 3M Diagnostic Systems, Inc. | MID | Class II | |
| K913027 | Vessel Dilator | Deseret Medical, Inc. | DRE | Class II | |
| K912641 | Biopro Ziralloy Modular Femoral Heads | Biopro, Inc. | LZO | Class II | |
| K912623 | Medical Tape | Renfrew Tape, Ltd. | KGX | Class I | |
| K912598 | Ace Cortical Bone Screw | Ace Medical | HWC | Class II | |
| K910991 | Shiley Therapeutic Autotransfusion System | Shiley, Inc. | CAC | Class II | |
| K905694 | Fvp-1000 Family and Fvp-1000D Family | Fischer Imaging Corp. | JAA | Class II | |
| K904236 | Endosseous Implants | Attachments Intl., Inc. | DZE | Class II | |
| K913871 | Floswitch(r) Hp | Boston Scientific Corporation | DQO | Class II | |
| K913869 | RF-Opaque Blanket for Magnetom System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K914967 | Sharp Endoknot Pusher | Sharpe Endosurgical Corp. | GCJ | Class II | |
| K914940 | Beltone Clearvoice | Beltone Electronics Corp. | ESD | Class I | |
| K914939 | Otosonic Acs-Asp | Beltone Electronics Corp. | ESD | Class I | |
| K914833 | Immulite Digoxin | Cirrus Diagnostics, Inc. | DPO | Class II | |
| K914785 | Wheelchariot Lightweight Manual Wheelchair | Wheelchariots, Inc. | IOR | Class I | |
| K914750 | Roche Cobas(r) Ammonia and Ethanol Calibrator | Roche Diagnostic Systems, Inc. | JIX | Class II | |
| K914674 | Microair 3500 | Gsi Development Co. | IOQ | Class II |