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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K183090 | Relieva Tract Balloon Dilation System | Acclarent Inc | QGK | Class I | |
| K183056 | ASSURE® Anterior Cervical Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | PLC | Class II | |
| K180065 | FUSION Plus Curing Light | Dentlight Inc. | EBZ | Class II | |
| DEN180041 | Monarch eTNS System | Neurosigma, Inc. | QGL | Class II | |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | KCI USA, Inc. | QFC | Class II | |
| K190788 | Disposable Standard Clamp | Standard Bariatrics | GCJ | Class II | |
| K190644 | Guide Sheath | Surmodics, Inc. | DYB | Class II | |
| K190506 | NeoForm Annuloplasty Ring | Genesee BioMedical, Inc. | KRH | Class II | |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical LLC | MAX | Class II | |
| K190109 | MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K183601 | CryoTouch | Cryoconcepts LP | GEH | Class II | |
| K183593 | Lung Vision System | Bodyvision Medical, Ltd. | LLZ | Class II | |
| K182457 | Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J | Brivant Limited (Lake Region Medical) | DQX | Class II | |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | Psychemedics Corp. | DJG | Class II | |
| K181747 | Orthodontic Appliance | Shandong Huge Dental Material Corporation | NXC | Class II | |
| K190728 | Arthrex SwiveLock Anchors | Arthrex GmbH | MBI | Class II | |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K190688 | VersaCross Steerable Sheath, VersaCross Transseptal Dilator | Baylis Medical Co., Inc. | DYB | Class II | |
| K190369 | M-Y Sheath | Ram Medical Innovations, Inc. | DYB | Class II | |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | DHR | Class II | |
| K190082 | Straumann BLX Variobase Abutment | Straumann USA, LLC | NHA | Class II | |
| K183638 | SmartLinx Vitals Plus Patient Monitoring System | Capsule Technologie | MWI | Class II | |
| K183634 | Stasis Monitoring System | Stasis Labs, Inc. | MWI | Class II | |
| K183584 | JO H2O Jelly Original Personal Lubricant | United Consortium | NUC | Class II | |
| K183403 | JETi 88 Peripheral Thrombectomy System | Walk Vascular, LLC | QEZ | Class II | |
| K183395 | Arthrex 2.5 mm Tenodesis Screw | Arthrex GmbH | HWC | Class II | |
| K183189 | Ultra OTC Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | |
| K183152 | Phoenix | Us Bionics, Inc. (dba Suitx) | PHL | Class II | |
| K183043 | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter | Imperative Care Inc. | NRY | Class II | |
| K182998 | Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd | OCX | Class II | |
| K182944 | Dr. Amplatz Micro Plug | KA Medical | KRD | Class II | |
| K182702 | SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I. Inc. | CGS | Class II | |
| K181988 | eMurmur ID | Csd Labs GmbH | DQD | Class II | |
| K190773 | Elecsys TSH | Roche Diagnostics GmbH | JLW | Class II | |
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation | FAE | Class II | |
| K183428 | Avulsion Forceps | STERIS Corporation | KGE | Class II | |
| K183332 | “BRAXX” Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | JAQ | Class II | |
| K183302 | KY Banksy Aloe | Rb Health (Us), LLC | NUC | Class II | |
| K182999 | General Cutting Contra Handpiece | Nakanishi Inc. | EGS | Class I | |
| K182246 | Mist Ic | Imagine Milling Technologies, LLC | NHA | Class II | |
| K182217 | Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use | Ezisurg (Suzhou) Medical Co., Ltd. | GDW | Class II | |
| K181541 | Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK | Andon Health Co., Ltd | MWI | Class II | |
| K190705 | WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream | Wholepower Biotech Co., Ltd. | LCX | Class II | |
| K190420 | NDOHD High Definition Imaging System (NDOHD) | Altaravision, Inc. | LLZ | Class II | |
| K190320 | PreXion3D Explorer | Prexion Corporation | OAS | Class II | |
| K190072 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K182924 | Diode Laser Treatment System | Weifang KM Electronics Co., Ltd | GEX | Class II | |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | Medline ReNewal | NLM | Class II |