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 |
|---|---|---|---|---|---|
| K193426 | Elite iQ | Cynosure, LLC | GEX | Class II | |
| K193425 | Pre-Milled Blank | ARUM DENTISTRY Co., Ltd. | NHA | Class II | |
| K193262 | DR 600 with Tomosynthesis | Agfa N.V. | IZF | Class II | |
| K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | OEB | Class II | |
| K192815 | Elecsys BRAHMS PCT | Roche Diagnostics GmbH | PRI | Class II | |
| K192574 | Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | Fisher & Paykel Healthcare, Inc. | MNT | Class II | |
| K183570 | LiquiBand Plus | Advanced Medical Solutions Limited | MPN | Class II | |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | JAA | Class II | |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | FTM | Class II | |
| K200310 | 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality | Stryker Corp. | GCJ | Class II | |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | Abbott (Formerly Thoratec Corporation) | DWA | Class II | |
| K200304 | EPIQ Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | NKB | Class II | |
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | Leica Biosystems Newcastle Ltd. | MXZ | Class II | |
| K192813 | Plasma IQ | Neauvia North America, Inc | GEI | Class II | |
| K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | EOQ | Class II | |
| K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V | MEDLINE INDUSTRIES, LP - Northfield | KGO | Class I | |
| K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | NKB | Class II | |
| K191583 | PhotonBlade with Smoke Evacuation | Invuity, Inc. | GEI | Class II | |
| K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems | PFW | Class II | |
| K191566 | Avinent Surgical Tray | Avinent Implant System S.L.U. | KCT | Class II | |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | Horiba Abx SAS | DBF | Class II | |
| K191031 | NightOwl | Ectosense NV | MNR | Class II | |
| K190918 | SwabTip Male Disinfectant Cap | Abbott Medical | QBP | Class II | |
| K190652 | OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant | OSSIO, Ltd. | HTY | Class II | |
| K200360 | TrackX | Track X Technology, LLC | OWB | Class II | |
| K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Dentsply Sirona Inc | NHA | Class II | |
| K193402 | ALLthread PEEK Suture Anchor | Zimmer GmbH | MBI | Class II | |
| K193229 | Transpara | Screenpoint Medical | QDQ | Class II | |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | Stereotaxis Inc | PJB | Class II | |
| K193139 | ProVecta 3D Prime Ceph | Durr Dental SE | OAS | Class II | |
| K193101 | Omnifix Low Dead Space Luer Lock Syringe | B.Braun Medical, Inc. | FMF | Class II | |
| K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | ONF | Class II | |
| K192697 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical Inc. | PKL | Class II | |
| K192590 | Cura 778 | Fmi Medical Systems, Inc. | JAK | Class II | |
| K191991 | Ezfil | Meta Biomed Co., Ltd. | EBF | Class II | |
| K191709 | V-STRUT Vertebral Implant | Hyprevention SAS | NDN | Class II | |
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | SSI Diagnostica A/S | MJH | Class II | |
| K190993 | Kinepict Medical Imaging Tool version v2.2 | Kinepict Health, Ltd. | LLZ | Class II | |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters | Bard Access Systems, Inc. | MSD | Class II | |
| K200314 | Capere Thrombectomy System | Vascular Medcure, Inc. | QEW | Class II | |
| K200269 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | LOX | Class II | |
| K200262 | L100 Go System | Bioness, Inc. | GZI | Class II | |
| K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | MBI | Class II | |
| K193616 | ARIX Ankle System | Jeil Medical Corporation | HRS | Class II | |
| K193389 | Vista Clear | Inter-Med/Vista Dental Products | MVL | Unclassified | |
| K193374 | TumEase Acupressure Bracelets | Mumease | MVV | Unclassified | |
| K193019 | DANNIK Disposable Monopolar Laparoscopic Instrument | Dannik | GEI | Class II | |
| K192906 | Mecta-C Stand Alone | Medacta International SA | OVE | Class II |