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 |
|---|---|---|---|---|---|
| K002551 | Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019ul, 4G109ul | Siemens Healthcare Diagnostics Inc. | LEG | Class II | |
| K002345 | Surgi-Vision Urethral Coil | Surgi-Vision, Inc. | MOS | Class II | |
| K002318 | United #1018-Freedom Series, United #2018-Comfort Series, United #3018-Elegance Series, United #5018-Master Series | United Chair Mfg., LLC | INO | Class II | |
| K002179 | Magnetom Allegra System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K002125 | Pins and Wires | Implant Resource Inc | HTY | Class II | |
| K001835 | Irv2000 Individual Recreational Vehicle | Trac About, Inc. | INI | Class II | |
| K000995 | Narkomat, Model 2000 | Heyer America, Inc. | BSZ | Class II | |
| K002978 | Ligthspeed 3.0 CT Scanner System | GE Healthcare | JAK | Class II | |
| K002497 | Model 4810 Analyzer Output Adapter | Pace Medical | DTC | Class II | |
| K002496 | Model 4815 Adapter | Pace Medical | DTN | Class II | |
| K002355 | Atom Infa Warmer V-505 | Atom Medical Corporation | FMT | Class II | |
| K002152 | Track 1.0 & 1.5 Mm Systems-Tissue Regeneration by Alveolar Callus Distraction | KLS-Martin L.P. | MQN | Class II | |
| K002140 | Menicon Progent Remover | Menicon Co. Ltd. | MRC | Class II | |
| K002104 | Combined Physiological Monitoring System | Maryrose Cusimano, Ph.D. & Scott Zeff | IKN | Class II | |
| K001719 | Q-Lux Plasma 100 Light Cure Unit | Rolence Enterprise Co., Ltd. | EBZ | Class II | |
| K000927 | Alliger Ultrasonic Surgical System Model Auss-4 | Misonix, LLC | LFL | Unclassified | |
| K991296 | Tutopatch | Tutogen Medical U.S., Inc. | FTM | Class II | |
| K002998 | Biomet Bi-Polar Shoulder System | Zimmer GmbH | KWT | Class II | |
| K002939 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Senors Oximeter | Masimo Corporation | DQA | Class II | |
| K002729 | Synthes Proximal Humeral Nail | Synthes (USA) Products LLC | JDS | Class II | |
| K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | KWQ | Class II | |
| K002557 | Suture Welding System and Kit-(J-Tip Design) | TORNIER Inc. | GAW | Class II | |
| K002523 | Advantage Drive System | Linvatec Corporation | HBC | Class II | |
| K002332 | EEG Spike and Event Detector Module | Excel Tech., Ltd. | OMB | Class II | |
| K002228 | Photon Modular Workstation System, Models Z-12834-X & Z-13175-X | Paradigm Medical Industries, Inc. | GEX | Class II | |
| K002110 | Spl Crimp System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | JDQ | Class II | |
| K002094 | Bard Memotherm Covered Esophageal Stent, Model Multiple | C.R. Bard Inc | ESW | Class II | |
| K002082 | Speedlink Transverse Connector | Spinal Concepts, Inc. | KWP | Class II | |
| K001742 | Resusci Inflate-a-Shield CPR Barrier | Laerdal Medical a/S | CBP | Class II | |
| K001519 | Acticoat 7 Dressing | Westaim Biomedical, Inc. | FRO | Unclassified | |
| K002879 | Modification to Bioplate Bioclip Craniotomy Fixation System | Bioplate Inc | JEY | Class II | |
| K002857 | Els Cannula (Kit), Model M1210-88,M1510-88 | Jostra AG | DWF | Class II | |
| K002850 | Mwo-202 3D Hydraulic Coarse/fine Micromanipulator | Narishige Co., Ltd. | MQJ | Class II | |
| K002804 | N Protein Standard Sl | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K002802 | Rapid Exchange Tapertome | Boston Scientific Corporation | KNS | Class II | |
| K002799 | Paragon Cze 2000 Capillary Electrophoresis System and Buffer-100 | Siemens Healthcare Diagnostics Inc. | CFF | Class II | |
| K002777 | Vacuette with Ppack | Greiner Bio-One North America, Inc. | JKA | Class II | |
| K002760 | Elecsys Dhea-S Calset | Roche Diagnostics GmbH | JIS | Class II | |
| K002751 | Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables | Masimo Corporation | DQA | Class II | |
| K002674 | Randox Microalbumin | Randox Laboratories, Limited | DDZ | Class II | |
| K002505 | Xia Spine System | Howmedica Osteonics Corp | KWP | Class II | |
| K002478 | S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00a08 | GE Healthcare | MHX | Class II | |
| K002350 | Refacto Laboratory Standard | The Genetics Institute | GGP | Class II | |
| K002137 | Cathcor Desktop | Siemens Elema AB | DQK | Class II | |
| K002069 | Ascend Spinal Fixation System | Spinal Innovations, LLC | KWP | Class II | |
| K001607 | Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104) | Repromedix Corp. | CDP | Class II | |
| K001606 | Reprobead Tsh Enzyme Immunoassay Reagent Kit (Catalog# 107) | Repromedix Corp. | JLW | Class II | |
| K001603 | Reprobead T4 Enzyme Immunoassay Reagent Kit (Catalog# 105) | Repromedix Corp. | KLI | Class II | |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | CGA | Class II | |
| K000886 | Spirol Epidural Catheter | Abbott Medical | BSO | Class II |