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 |
|---|---|---|---|---|---|
| K020046 | Multigas Unit, Model Ag-920Ra | Nihon Kohden America Inc | CCK | Class II | |
| K014119 | Wu's 3-Wheeled Neo Scooter, Wt-M3 | Wu's Tech Co., Ltd. | INI | Class II | |
| K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | MNI | Class II | |
| K022120 | Mpf Acetabular Cup Generation 2 | Plus Orthopedics | LZO | Class II | |
| K022073 | Heartline Receiving Station | Aerotel Medical Systems (1998), Ltd. | DXH | Class II | |
| K021784 | Profeel Powder Free Polymer Coated Brown Latex Surgical Gloves, Sterile (Protein Labeling Claim) | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K021705 | Modification to Townley Transfacepedicular Screw Fixation System | Medtronic Sofamor Danek | MRW | Unclassified | |
| K021517 | Abp for Windows | Rozinn Electronics, Inc. | DSK | Class II | |
| K021499 | Cemvac Ultra Pre-Packed with Depuy 1 Bone Cement | Depuy Orthopaedics Inc. | LOD | Class II | |
| K021466 | Consensus Acetabular Insert, Cross-Linked Polyethylene | Hayes Medical, Inc. | LPH | Class II | |
| K021458 | Synthes in-Situ Bender/cutter | Synthes (USA) Products LLC | HRS | Class II | |
| K021376 | Datex-Ohmeda S/5 Critical Care Monitor with L-Icu02 and L-Icu02a Software | GE Healthcare | DSI | Class II | |
| K021322 | Endossous Implants | Intra-Lock International | DZE | Class II | |
| K020828 | Ca 125 Assay for the Advia Centaur System | Bayer Corp. | LTK | Class II | |
| K020103 | Prismaflo | Stihler Electronic GmbH | KOC | Class II | |
| K020004 | Clindatalink Version 1.0 for Spirometry | Compleware Corp. | BZG | Class II | |
| K022171 | Accu-Chek Compact System | Roche Diagnostics GmbH | NBW | Class II | |
| K022148 | Injex 30 Needle Free Injection System | Equidyne Systems, Inc. | KZE | Class II | |
| K022046 | Vital Scientific Coagulation Control,coagulation Control Level 1,2,3,Quikcoag Coagulation Control | VitalScientific | GGN | Class II | |
| K021822 | R120 Modular Total Hip System | Osteoimplant Technology, Inc. | JDI | Class II | |
| K021764 | Rusch Tracheofix Set, Cuffed and Uncuffed | Rusch Intl. | BTO | Class II | |
| K021685 | Venture Homefill II with Oxygen Conserver | Invacare GmbH | CAW | Class II | |
| K021681 | Micropaq, Models 402, 404 | Welch Allyn Protocol, Inc. | DRT | Class II | |
| K021516 | Diastat Anti Cyclic Citrullinated Peptide Elisa, Model Fccp 200 | Axis-Shield Diagnostics, Ltd. | NHX | Class II | |
| K021304 | Prolite Pulsed Light System | Big Sky Laser Technologies, Inc. | GEX | Class II | |
| K021114 | 'Rapidtec' 5A Multiple Dip Test | American Bio Medica Corp. | DKZ | Class II | |
| K020474 | Makrite Type N95 Respirator and Surgical Mask Model 910-N95 | Makrite Industries, Inc. | MSH | Class II | |
| K020356 | Alpha Mirage Top Tightening Spinal System | Alphatec Spine, Inc. | MNH | Class II | |
| K012974 | Prizm Medical Inc. Thermotrace Infrared Thermometer Models 15004 and 15007 | Prizm Medical, Inc. | FLL | Class II | |
| K012770 | Infinity Micro2+ | Siemens Medical Solutions USA, Inc. | DQA | Class II | |
| K011741 | Crit-Line Monitor III Tqa (Clm Tqa) | Hemametrics | FIL | Class II | |
| K022118 | Immulite Turbo Ck-Mb, Models Lskcp1 (100 Tests), Lskcp5 (500 Tests) | Siemens Healthcare Diagnostics Inc. | JHX | Class II | |
| K022070 | Xantus Anterior Lateral Supplemental Fixation System | Medtronic Sofamor Danek | KWP | Class II | |
| K022027 | Calibrating Material, Buffers, Standard | Mission Diagnostics | JIT | Class II | |
| K021461 | Atlantis Vision Anterior Cervical Plate System | Medtronic Sofamor Danek | KWQ | Class II | |
| K021313 | Search Evolution Total Knee System | Aesculap Inc | JWH | Class II | |
| K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek | MQV | Class II | |
| K020247 | Colorado 2 Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K020172 | Opus Magnum Anchor & Instrument Set | Opus Medical, Inc. | MBI | Class II | |
| K020119 | Vectorsonic, Model Vu-200 | Metron Medical Australia, Pty, Ltd. | IMG | Class II | |
| K022049 | Modification to Raichem Calcium Reagent | Hemagen Diagnostics, Inc. | CJY | Class II | |
| K022033 | Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation System | Bioplate Inc | JEY | Class II | |
| K022026 | Medtronic Ave Bridge Polaris Biliary Stent System (Polaris) | Medtronic, Inc. | FGE | Class II | |
| K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and without Side Holes) | Spire Biomedical, Inc. | MSD | Class II | |
| K021844 | Admira Protect | Voco GmbH | EBC | Class II | |
| K021671 | Jas Hdl Cholesterol (Automated) Reagent | JAS Diagnostics/Drew Scientific | LBS | Class I | |
| K021572 | Synchron Systems C-Reactive Protein (C-Rp) Reagent; Synchron Systems Cx C-Rp Calibrator | Siemens Healthcare Diagnostics Inc. | DCN | Class II | |
| K021524 | Light Cure Dental Dam | Prime Dental Manufacturing, Inc. | EIE | Class I | |
| K021475 | Bd Single Lumen Needle, Syringe and Blood Collection Set | BD | FMI | Class II | |
| K021437 | Secure Soft | Imtec Corp. | EBI | Class II |