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 |
|---|---|---|---|---|---|
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System in-Vitro Diagnostic System | Miles, Inc. | JHW | Class II | |
| K946204 | Scimed(r) Triduige(r) Guide Catheters | Scimed Life Systems, Inc. | DQY | Class II | |
| K946083 | Flutter(r) | Bradstreet Clinical Research Assoc., Inc. | BYI | Class II | |
| K946082 | Beech Pro Lok Fixed | Beech Medical Products, Inc. | FPA | Class II | |
| K945396 | Fluoro-Tip(r) Hemostasis Valve Introducer Set | B.Braun Medical, Inc. | DYB | Class II | |
| K944943 | Opti-Max Press-Fit External-Hex Dental | Opti-Max | DZE | Class II | |
| K944660 | Acute Central Venous Access Catheter Tray | Neostar Medical Technologies, Inc. | FOZ | Class II | |
| K944511 | Acute Central Venous Access Catheter (Acvac) | Neostar Medical Technologies, Inc. | FOZ | Class II | |
| K944143 | Ms Classique Balloon Catheter | Meadox Surgimed, Inc. | FGE | Class II | |
| K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | ArthroCare Corporation | HRX | Class II | |
| K943430 | Cervical Function Indicator | Whiplash Analysis, Inc. | LXJ | Class II | |
| K943195 | Coat-a-Count Neonatal Tsh Irma | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K943051 | Mycoakt M. Tuberculosis Cuulture Id Kit | Dynagen, Inc. | JSY | Class I | |
| K943050 | Mycoakt M Kansasii Culture Id Kit | Dynagen, Inc. | JSY | Class I | |
| K943049 | Mycoakt M. Avium Culture Id Kit | Dynagen, Inc. | JSY | Class I | |
| K942782 | Piccolo(tm) | Abaxis Inc | JJG | Class I | |
| K942458 | Precision-Multi-Sera - Human - Normal and Elevated | Randox Laboratories, Limited | JJY | Class I | |
| K942344 | Zoll Pd 1600 Semi-Automatic External Defibrillator | ZOLL Medical Corporation | MKJ | Class III | |
| K941851 | Dual Lumen Catheter (Dlc) Tray | Neostar Medical Technologies, Inc. | KOC | Class II | |
| K941427 | Serum @-Hydroxybutyrate Dehydrogenase (Hbdh) | Teco Diagnostics | JMK | Class I | |
| K941278 | Hy-Tec Automated Eia System | Hycor Biomedical | DHB | Class II | |
| K935544 | 3I Standard Threaded/self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | DZE | Class II | |
| K933883 | Gambro Fh 66 D Hemofilter | Cobe Renal Care, Inc. | KDI | Class II | |
| K950771 | Disposable Adhesive Face Mask | Advanced Warming Systems, Inc. | BSJ | Class I | |
| K950770 | CPR Microshield II | Plasco, Inc. | CBP | Class II | |
| K950769 | CPR Micromask Plus Catalog No 73-402 | Plasco, Inc. | CBP | Class II | |
| K950710 | Microquartz Medical Side-Firing Laser Fiber | Microquartz Medical, Inc. | GEX | Class II | |
| K950662 | Dermastat, Micronspot, Macrospot, Focalstat | Laserscope | GEX | Class II | |
| K950661 | Candela 10Mm Circular Spot Laser Handpiece | Candela Corporation | GEX | Class II | |
| K950031 | Varelisa Dsdna Antibodies (Farr Version) | Elias U.S.A., Inc. | LRM | Class II | |
| K946288 | Copan Venturi Transystem Liquid Amies Medium | COPAN Diagnostics, Inc. | JSM | Class I | |
| K946287 | Copan Venturi Transystem Amies Medium without Charcoal | COPAN Diagnostics, Inc. | JSM | Class I | |
| K946286 | Copan Venturi Transystem Cary-Blair Medium | COPAN Diagnostics, Inc. | JSM | Class I | |
| K946285 | Copan Venturi Transystem Stuarts Medium | COPAN Diagnostics, Inc. | JSM | Class I | |
| K946284 | Copan Venturi Transystem Amies Medium with Charcoal | COPAN Diagnostics, Inc. | JSM | Class I | |
| K946283 | Copan Venturi Transystem Liquid Stuarts Medium | COPAN Diagnostics, Inc. | JSM | Class I | |
| K945125 | Dupont Aca Vancomycin (Vanc) Method | The du Pont Co. | LEH | Class II | |
| K944933 | Immulite (Hpl) (Human Placental Plactogen) | Siemens Healthcare Diagnostics Inc. | JMF | Class II | |
| K944819 | Krdl 2000 | Physicians Consulting, Inc. | BXB | Class I | |
| K943882 | Abl5 Blood Gas System;bph5 Blood Ph System | Radiometer America, Inc | CHL | Class II | |
| K943416 | Delfia Neonatal Thyroxine Kit | Wallac Oy | CDX | Class II | |
| K943243 | Pulse Heart Rate Monitor | Sensor Dynamics, Inc. | DRT | Class II | |
| K943242 | Pro-Sport Heart Rate Monitor | Sensor Dynamics, Inc. | DRT | Class II | |
| K942694 | Stability System (110V) Model 945-300; Stability System (220V) Model #945-302 | Sport Medical Technology Inc | KHX | Class I | |
| K942444 | 3002 Aeromax | Medical Industries America, Inc. | CAF | Class II | |
| K934336 | Spinalplane | Synvasive Technology, Inc. | HSZ | Class I | |
| K933494 | Exactech Posterior Stabilized Cemented Total Knee System | Exactech, Inc. | JWH | Class II | |
| K931517 | Safe-Step | Lenjoy Engineering, Inc. | IRN | Class II | |
| K912456 | Sundt Slim-Line Graft Clips | Cerenovus, Inc. | HCH | Class II | |
| K950877 | Reusable Monopolar Forceps | Boston Surgical Products, Inc. | GEI | Class II |