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 |
|---|---|---|---|---|---|
| K052021 | V5ms Transducer and Mpt7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | ITX | Class II | |
| K051985 | Biovalve Mini-Ject Needlefree Injector | Biovalve Technologies, Inc. | KZE | Class II | |
| K051918 | Resolve Open Back Halo Rings | Jerome Medical | HAX | Class II | |
| K051901 | Nio 3Mp-21 | Barco N.V. | LLZ | Class II | |
| K051793 | Encore Sterile Powder-Free Latex Surgical Glove with Proprietary Coating (Containing Glycerine) | Ansell Healthcare Products LLC | KGO | Class I | |
| K051758 | Penumbra Aspiration Pump, Model 115V | Penumbra Inc. | BTA | Class II | |
| K051706 | Iq Body Fluids Control | Streck LLC | JPK | Class II | |
| K051597 | Stratus Cs D-Dimer | Siemens Healthcare Diagnostics Inc. | DAP | Class II | |
| K051522 | Silbroncho Double Lumen Tube | Fuji Systems Corp. | CBI | Class II | |
| K051178 | Mee-1000A Neuromaster | Nihon Kohden America Inc | GWF | Class II | |
| K050644 | Vancouver Biotech Human Cardiac Troponin I Immunoassay Test Kit | Vancouver Biotech, Ltd. | MMI | Class II | |
| K052165 | Rx Accunet Embolic Protection System | Boston Scientific Corporation | NTE | Class II | |
| K052128 | 3M Attest 293 Auto-Reader, 3M Attest 293G Auto-Reader | 3M Company | FRC | Class II | |
| K052096 | Nubic Spinal Implant | Signus Medical, LLC | MQP | Class II | |
| K052077 | G-Scan Cervical Spine Coil | Esaote S.p.A. | MOS | Class II | |
| K052071 | Lysus Infusion System | Ekos Corp. | QEY | Class II | |
| K052054 | Tsrh Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K052044 | Acmi Autoclavable Ureteroscope, Models Mr-6A and Mr-6Al | Acmi Corporation | FGB | Class II | |
| K052038 | Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System | Boston Scientific Corporation | LIT | Class II | |
| K052034 | Terumo Syringe With/without Needle | Terumo Medical Corp. | FMF | Class II | |
| K051930 | Drug Access Spike | Medegen Medical Manufacturing Services | FMF | Class II | |
| K051923 | Powdered Vinyl Patient Examination Gloves White (Non-Colored) | Shijiazhuang Wonder Plastic Co., Ltd. | LYZ | Class I | |
| K051849 | Vitek 2 Gram Positive Ertapenem for Streptococcus Pneumoniae | bioMerieux, Inc. | LON | Class II | |
| K051794 | Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis | Office of the Surgeon General, U.S. Army | NVQ | Class II | |
| K051633 | Cd-Chex Plus Bc | Streck LLC | GGL | Class II | |
| K051526 | Uritek-720+ Urine Analyzer | Teco Diagnostics | KQO | Class I | |
| K051364 | Vpap Adapt | ResMed Corp | MNS | Class II | |
| K051282 | Ventana Image Analysis System - Her2/neu | Becton Dickinson & Co | NOT | Class II | |
| K051095 | 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Optical Connection, Inc. | LPL | Class II | |
| K050971 | Biovalve Insulin Delivery Systems (Bids) | Biovalve Technologies, Inc. | LZG | Class II | |
| K050840 | Modification to Duet System | Bioview | JOY | Class II | |
| K050821 | Coagcare Anticoagulation Management System | Zycare | KQG | Class II | |
| K050613 | Quantia Beta-2 Microglobulin | Biokit, S.A. | JZG | Class II | |
| K050493 | Quantia Ige | Biokit, S.A. | DGC | Class II | |
| K050222 | Vanguard Anterior Stabilized Tibial Bearings | Zimmer GmbH | MBH | Class II | |
| K050183 | Silfab Super 2 Max Compressor, N28 Series | Silvestrin Fabris S.r.l. | CAF | Class II | |
| K052130 | Vita in-Ceram 2000 Al Cubes for Inlab, Models Al20/al40 | Vident | EIH | Class II | |
| K051972 | Karl Storz Trans-Nasal Esophagoscope | Karl Storz Endoscopy-America, Inc. | EOX | Class II | |
| K051840 | Ensite Verismo Software | Abbott Medical | LLZ | Class II | |
| K051819 | C Change Solution Warmer | C Change Surgical LLC | LHC | Class I | |
| K051813 | Ultrapacs | Ultrarad Corporation | LLZ | Class II | |
| K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System | Medical Insight A/S | LLZ | Class II | |
| K051786 | Melide Fiberoptic Light | Designs for Vision, Inc. | FST | Class II | |
| K051709 | Hippocampe Wheelchair | Vipamat Technologie | IQC | Class II | |
| K051700 | Opticlean Lens Irrigator & Optidock Tissue Ligator | Medchannel, LLC | GAM | Class II | |
| K051615 | Sterling Cancellous Chips; Sterling Cancellous Cubes | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | Class II | |
| K051613 | Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 3 | Olympus Medical Systems Corp. | ODA | Class II | |
| K051420 | Habib 4X | Emcision, Ltd. | GEI | Class II | |
| K051302 | Excel Bariatric or Excel Shuttle Wheelchair | MEDLINE INDUSTRIES, LP - Northfield | IOR | Class I | |
| K051131 | Vcs S3t | Cycling and Health Tech. Industry R&D Center/Chc | INI | Class II |