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 |
|---|---|---|---|---|---|
| K253879 | Monofix Pdo | Samyang Holdings Corporation | NEW | Class II | |
| K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | GEI | Class II | |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | FMF | Class II | |
| DEN250049 | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | Abbott Diabetes Care | SJD | Class II | |
| K261381 | TiLink-L™ SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | |
| K260604 | BiWaze Clear System | Abmrc, LLC | NHJ | Class II | |
| K260246 | SEISMIQ™ Intravascular Lithotripsy System | Bolt Medical, Inc. | PPN | Class II | |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | HWC | Class II | |
| K254286 | Guided Bone Regeneration System | DentalMaster(Xiamen)Medical Technology Co., Ltd. | DZL | Class II | |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. | IYN | Class II | |
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | JDI | Class II | |
| K260691 | Btl-699 | BTL Industries, Inc. | OBP | Class II | |
| K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | GAT | Class II | |
| K262538 | Artix™ MT;Artix™ Thin-Walled Sheath | Inari Medical, Inc. | QEW | Class II | |
| K262127 | DS Core CBCT Anatomy | Dentsply Sirona | QIH | Class II | |
| K262089 | Disposable Warming Blanket | Hangzhou Tappa Medical Technology Co., Ltd. | DWJ | Class II | |
| K262074 | Any-Zircos | Mediclus Co., Ltd. | EIH | Class II | |
| K262005 | Affera Integrated Mapping System | Medtronic, Inc. | DQK | Class II | |
| K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | OVE | Class II | |
| K261710 | AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors | Apyx Medical Corporation | QPB | Class II | |
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | MOB | Class II | |
| K261354 | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | ITI | Class II | |
| K261015 | Solo Scope Colonoscope System | Gi View, Ltd. | FDF | Class II | |
| K260643 | Cimilre Dual Max | Cimilre Co., Ltd. | HGX | Class II | |
| K260584 | BoneMRI | Mriguidance B.V. | QIH | Class II | |
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | Immunodiagnostics Systems Limited | LLL | Class II | |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | MBH | Class II | |
| K253726 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | |
| K253699 | Tempus ECG-PH | Tempus AI, Inc. | SAT | Class II | |
| K253692 | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | DQK | Class II | |
| DEN250067 | ReneuRx™ (Neural Ice) | Brixton Biosciences | SJA | Class II | |
| DEN250026 | Avulux | Matap Ii, LLC | QEO | Class I | |
| K262515 | Kneu Platform (V2) | Kneu Health Digital , Ltd. | GYD | Class II | |
| K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | OLO | Class II | |
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10) | Hardy Diagnostics | JTN | Class II | |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | |
| K261049 | Scala® Tl | Spineart SA | MAX | Class II | |
| K260817 | MIRA Surgical System | Virtual Incision | SAB | Class II | |
| K260579 | Infinity® Acute Care System (IACS) – VG8.1 | Draeger Medical Systems, Inc. | MHX | Class II | |
| K260242 | CPETWise Platform | Medibyt , Ltd. | BTY | Class II | |
| K253807 | Valence InVent Xtend™ (CVG-4101-VXA) | Convergence Medical Sciences , Ltd. | MOD | Class II | |
| DEN250043 | Qoramatic Automated Stool Management | Cm Technologies, Inc. | SJB | Class II | |
| K262622 | Swoop® Portable MR Imaging® System | Hyperfine, Inc. | LNH | Class II | |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | |
| K262070 | Diode Laser Therapy Systems (DL612A) | Hebei Zollvan Medical Technology Co., Ltd. | GEX | Class II | |
| K261964 | Echolaser X4 | Elesta S.P.A | GEX | Class II | |
| K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | SET | Class II | |
| K261413 | Extron 3;Extron 6 | DRTECH Corporation | OWB | Class II | |
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) | CooperSurgical, Inc. | MQG | Class II | |
| K260799 | Nipro Dry Acid Concentrate Mixer | Nipro Technical Solutions, Incoporated | KPO | Class II |