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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | PHX | Class II | |
| K260498 | TriMemo™ SEMIRIGID ANNULOPLASTY RING | Corcym Inc. | KRH | Class II | |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | GE Healthcare | QIH | Class II | |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) | Shenzhen Dongjiang Technology Co., Ltd. | BTA | Class II | |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia SL | CBK | Class II | |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K240974 | SPRINT PNS System | SPR Therapeutics, Inc | SCN | Class II | |
| K260965 | CVAC Aspiration System | Calyxo, Inc. | FED | Class II | |
| K260340 | Hc Biologics Osteopoint Peek Cages, Hc Biologics Osteopoint Cervical Peek Cages, Hc Biologics Osteopoint Lumbar Peek Cages | HC Biologics LLC | ODP | Class II | |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific LLC | QYT | Class II | |
| K260091 | Aventus Introducer Sheath | Inquis Medical, Inc. | DYB | Class II | |
| K254128 | InSet Reverse Total Shoulder System | SHOULDER INNOVATIONS, Inc | PHX | Class II | |
| K254078 | Hvt 2.0 | Vapotherm Inc. | BTT | Class II | |
| K253861 | Acorys Mapping System | Corify Care S.L | DQK | Class II | |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Zimmer GmbH | MBF | Class II | |
| K253357 | b-ONE® Bipolar Head | b-ONE Ortho Corp. | KWY | Class II | |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics GmbH | QVP | Class II | |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, LLC | DYB | Class II | |
| K260508 | LOBO Vascular Occlusion System | Okami Medical Inc. | KRD | Class II | |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | KLE | Class II | |
| K260244 | Auryon Atherectomy System | Eximo Medical Ltd | MCW | Class II | |
| K260090 | SMART Osteotomy System | Actis Medical | HRS | Class II | |
| K260082 | TRIOS Dx (R1) | 3SHAPE Trios a/S | SHQ | Class II | |
| K254004 | Vrnt | CognifiSense, Inc. | QRA | Class II | |
| K253930 | Overjet Iris Intelligent Imaging System | Overjet | QIH | Class II | |
| K253926 | Diacore | ShenB Co., Ltd. | NGX | Class II | |
| K253917 | ARION ARC System | Plasma Surgical Inc. | GEI | Class II | |
| K253777 | Ascblue (8010) | Ascblue Corporation | GEI | Class II | |
| K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | QIH | Class II | |
| K253657 | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads | Covidien (Part of Medtronic) | GDW | Class II | |
| K253510 | Freestyle Mini Hands-free | Medela AG | HGX | Class II | |
| K253446 | AeroDR TX c02 | DK Medical Systems Co., Ltd. | KPR | Class II | |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | DQY | Class II | |
| K252942 | ShaeferH | Shaeferh, LLC | LRK | Class II | |
| K252757 | CeQur Simplicity™ On-Demand Insulin Delivery System | CeQur SA | OPP | Class II | |
| K252708 | Relu Cloud | Relu BV | QIH | Class II | |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | HWC | Class II | |
| K252548 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | QKB | Class II | |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder | Becton Dickinson & Co | JKA | Class II | |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | 1987 Media Limited | OBR | Unclassified | |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton Dickinson & Co | JKA | Class II | |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. | MHX | Class II | |
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | GWM | Class II | |
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals ApS | CHL | Class II | |
| K252190 | DeepBT Detector-Plus | Aitewan Biomedical Technology, Inc. | QKB | Class II | |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors LLC | NHA | Class II | |
| K260462 | Rct800 | Ray Co., Ltd. | OAS | Class II | |
| K260317 | Artelon Convenience Kits | International Life Sciences | QWJ | Class II | |
| K260245 | SILKBridge | Klisbio, Inc | JXI | Class II | |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | EIH | Class II |