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 |
|---|---|---|---|---|---|
| K994051 | Hardydisk Doxycycline, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K993897 | Cergogold | Degussa - Ney Dental, Inc. | EIH | Class II | |
| K993789 | Clinical Blood Gas Mixture | General Air Service and Supply | CHL | Class II | |
| K993636 | Mdi Ss-a Test | Micro Detect, Inc. | LJM | Class II | |
| K993635 | Mdi Sm/rnp Test | Micro Detect, Inc. | LJM | Class II | |
| K993560 | Frialit-2 Bone Profiler | Friadent GmbH | DZE | Class II | |
| K993522 | Aktina Medical Physics Corporation Tennis Racquet Insert | Aktina Medical Physics Corp. | JAI | Class II | |
| K993411 | Femiscan Clinic System, Model Fs-Ictra and Femiscan Personal System, Model Fs-Hmtr | Mega Electronics, Ltd. | HIR | Class II | |
| K993151 | Radid Drug Screen 5-Panel Test | American Bio Medica Corp. | DJG | Class II | |
| K992998 | Automated Ophthalmics Softips | Automated Ophthalmics Inc | HKY | Class II | |
| K992859 | Abl700 Series Analyzer with Autocheck Module | Radiometer America, Inc | CHL | Class II | |
| K992767 | Browne Packaging and Label Steam Process Indicator | Sybron Dental Specialties, Inc. | JOJ | Class II | |
| K992744 | Midmark M4*9 Easyclave Steam Sterilizer | Midmark Corp | FLE | Class II | |
| K992016 | Amukin D | Amuchina Intl., Inc. | LIF | Class II | |
| K991962 | Eis Dynamic Memory Staples System | Groupe Lepine | JDR | Class II | |
| K991391 | Pvp, Polyvinylpyrrolidone 10% (W/v) in Hepes-Htf | Advanced Reproductive Technologies | MQL | Class II | |
| K994326 | Ascent Knee System | Biomet Manufacturing Corp | KWH | Class II | |
| K994272 | Automated Core Biopsy Device | Promex, Inc. | KNW | Class II | |
| K994156 | Modification to Cordis Palmaz Corinthian Iq Transhepatic Biliary Stent, Models Pq294b, Pq394b | Cordis US Corp. | FGE | Class II | |
| K993493 | The Autotac System | BioHorizons Implant Systems Inc | DZL | Class II | |
| K993429 | Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Z40 | Rossmax International Ltd. | DXN | Class II | |
| K993426 | Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Z44 | Rossmax International Ltd. | DXN | Class II | |
| K993039 | Viscous Fluid Injector System Module (Cx5700) | Bausch & Lomb Incorporated | MRH | Class II | |
| K992911 | Magstim Rapid | Magstim Corporation US | GWF | Class II | |
| K992455 | Nihon Kohden Ogs-2001A Pocketcare and Accessories | Nihon Kohden America Inc | DQA | Class II | |
| K992285 | Salter Aire Compressor | Salter Labs | CAF | Class II | |
| K990962 | Flosense, Model 29-8010 | Sdi Diagnostics, Inc. | JAX | Class II | |
| K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | KGN | Unclassified | |
| K993892 | Duraglide Stone Removal Balloon, Model 000635-38, 000646-47, Duraglide Stone Balloon, Model 007124-25,007144-45 | C.R. Bard Inc | FGE | Class II | |
| K993778 | Hydrotower Management System, Model 4-750-00 | Northgate Technologies Inc. | OCX | Class II | |
| K993738 | Dispos-a-Scope | Dispos-A-Scope | FER | Class II | |
| K993400 | Hdr Contour Tp Template and Implant Accessories | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K993392 | Bard Memotherm Flexx Biliary Stent | C.R. Bard Inc | FGE | Class II | |
| K992101 | Criterion 40 or Pm 40 | Caradyne, Ltd. | CAP | Class II | |
| K991959 | Psi Titanium Aneurysm Clip | V. Mueller Neuro/Spine | HCH | Class II | |
| K990803 | Medisystems Buttonhole Needle Sets | Medisystems Corp. | FIE | Class II | |
| K983866 | Belmont Model Ngpbp Intra-Aortic Balloon Pump | Belmont Medical Technologies | DSP | Class II | |
| K994253 | Vaclok Syringe | Merit Medical Systems, Inc. | FMF | Class II | |
| K993949 | Solo-Care Brand Hard Solution | Alcon Laboratories | MRC | Class II | |
| K993585 | Varelisa Tpo Antibodies, Model 12348/12396 | Pharmacia & Upjohn Company LLC | JZO | Class II | |
| K993407 | Ohmeda Medical Omnibed | GE Healthcare | FMZ | Class II | |
| K993376 | Enstylet Models Ec0010, Ec0020 | Endocardial Solutions, Inc. | DRB | Class II | |
| K993210 | Access Hybritech Free Psa Qc, Model 37219 | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K994252 | Introducer Sheaths, Vessel Dilator, Guidewire | Boston Scientific Corporation | DYB | Class II | |
| K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | Medtronic, Inc. | KRA | Class II | |
| K993463 | Intravascular Administration Set | Custom Assemblies Inc | FPA | Class II | |
| K993361 | Tubing Extension Set | Hurricane Medical | MSR | Class II | |
| K991647 | Tfx Medical Introducer Kit | Tfx Medical Group | DYB | Class II | |
| K994251 | Ketac-Molar Quick | Espe Dental AG | EBF | Class II | |
| K994111 | Celsite, Models St401l, St405l | B. Braun/Mcgaw | LJT | Class II |