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 |
|---|---|---|---|---|---|
| K242810 | RadUnity (Version 1.0.0) | Radunity Corp. | LLZ | Class II | |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K242631 | REGENETEN™ Bioinductive Implant | Smith & Nephew, Inc. | OWY | Class II | |
| K242559 | Digital Temp | Sprintray Inc. | EBG | Class II | |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Riverpoint Medical, LLC | MBI | Class II | |
| K242318 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | ASG Superconductors S.p.A. | LNH | Class II | |
| K242049 | SureCath Set | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K241995 | HyperFlex™ Bunion Correction System | Footbridge Medical | HRS | Class II | |
| K241390 | NeuroMatch | Lvis Corporation | OMB | Class II | |
| K240897 | Cellinew | VIOL Co., Ltd. | GEI | Class II | |
| K240818 | R2P Radifocus Glidewire Advantage | Terumo Corp. | DQX | Class II | |
| K240650 | LungProtect | Traferox Technologies Inc. | KDN | Class II | |
| K231859 | PrimmaArt | Dentscare Ltda | EBG | Class II | |
| K231655 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Corp. | NKB | Class II | |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. | PQA | Class II | |
| K243162 | World Liner | Signature Orthopaedics Pty Limited | MEH | Class II | |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International Ltd. | DQD | Class II | |
| K242538 | 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M | 3M Company | FRC | Class II | |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | PHX | Class II | |
| K242245 | Customized Abutment | ARUM DENTISTRY Co., Ltd. | NHA | Class II | |
| K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical Inc. | QEY | Class II | |
| K241831 | Transpara (2.1.0) | Screenpoint Medical | QDQ | Class II | |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona Inc | DZE | Class II | |
| K241588 | Electric Wheelchair (KR8803) | Zhejiang Kairui Medical Device Co., Ltd. | ITI | Class II | |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | GXY | Class II | |
| K232982 | EMS Sculpt Machine | Shandong Huamei Technology Co.,Ltd. | NGX | Class II | |
| K232588 | Aluna 2 | Knox Medical Diagnostics | BZH | Class II | |
| K243334 | Nooro Body & Foot Stimulator (SM9141, SM9142) | XF Agencija Limited | NUH | Class II | |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | |
| K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | GCJ | Class II | |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | LBH | Class II | |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd | EBI | Class II | |
| K242722 | Manual Wheelchair (MASY23) | Sichuan AST Medical Equipment Co., Ltd | IOR | Class I | |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer GmbH | MBH | Class II | |
| K242259 | Cala kIQ | Cala Health, Inc. | QBC | Class II | |
| K242203 | BriefCase-Quantification | Aidoc Medical Ltd. | QIH | Class II | |
| K242094 | Dreem 3S | Beacon Biosignals, Inc. | OLZ | Class II | |
| K242002 | FemVue MINI Saline-Air Device | Femasys Inc. | LKF | Class II | |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K241529 | Powered Wheelchair (NXN20-209) | Zhejiang Nysin Medical Co., Ltd. | ITI | Class II | |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | KNT | Class II | |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | GZI | Class II | |
| K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation dba Conventus Flower Ortho | HWC | Class II | |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | LCP | Class II | |
| K243405 | Xpert vanA | Cepheid | NIJ | Class II | |
| K242998 | GMReis Ankle Plating System | GM dos Reis Industria e Comercio Ltda | HRS | Class II | |
| K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | JAK | Class II | |
| K242871 | ATTUNE™ Revision Hinge Knee | Depuy Ireland UC | KRO | Class II | |
| K242799 | PliaFX Flo | LifeNet Health | MBP | Class II |