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 |
|---|---|---|---|---|---|
| K261202 | ENTire IRE System | ENTIRE MEDICAL Ltd | GEI | Class II | |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave Inc | MAX | Class II | |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical | OLO | Class II | |
| K261038 | Xpert PFP | Newclip Technics | HRS | Class II | |
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | Interojo Inc. | LPL | Class II | |
| K260489 | LASEmaR 1500 | Eufoton S.r.l. | GEX | Class II | |
| K260262 | Injection Needle | Mirco-Tech (Nanjing) Co., Ltd. | FBK | Class II | |
| K260138 | LUNE PureHygiene | Enamel Pure Inc. | GEX | Class II | |
| K260077 | OrthoGrid Hip AI® 4.0 | Orthogrid Systems, Inc | QIH | Class II | |
| K254300 | eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) | Anker Innovations Limited | HGX | Class II | |
| K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard Inc | FCM | Class II | |
| K253119 | CoSense ETCO Monitor | Capnia Inc | CCJ | Class II | |
| K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | JAA | Class II | |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | CAW | Class II | |
| K252947 | HistoSonics® Planning Tool | Histosonics, Inc | QTZ | Class II | |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | DQK | Class II | |
| K252840 | M12 Telemetry System | Global Instrumentation Corp. | MHX | Class II | |
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Boblingen GmbH | DQA | Class II | |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen BI-Rich Medical Devices Co., Ltd | BZH | Class II | |
| K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos de Saúde | IRP | Class II | |
| K261405 | Andi 2.2 | Imeka Solutions Inc. | QIH | Class II | |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Corp. | IZI | Class II | |
| K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | NFO | Class II | |
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd | FDF | Class II | |
| K260295 | Helio Kids; Apex P | Motion Composites | IOR | Class I | |
| K260213 | BD BACTEC FXI Culture System | Lee Laboratories, Inc. | MDB | Class I | |
| K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | MUE | Class II | |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex GmbH | MAI | Class II | |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | MAX | Class II | |
| K253530 | Trexon™ Monofilament Synthetic Absorbable Suture | Medtronic, Inc. | GAM | Class II | |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal LLC | FRG | Class II | |
| K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA Inc | GZJ | Class II | |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | Bioptimal International Pte. Ltd. | DQO | Class II | |
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer GmbH | MBH | Class II | |
| K261374 | LigaPASS™ System | Medicrea International S.A.S | OWI | Class II | |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips North America LLC | IYN | Class II | |
| K260646 | Renasys Edge (66803126) | Smith & Nephew Medical Ltd | OMP | Class II | |
| K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | EHD | Class II | |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | MUJ | Class II | |
| K260142 | StimelMD (SSMD) system | Motion Informatics Ltd. | IPF | Class II | |
| K260123 | EPIQ Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K254265 | Helion Viewer Suite | Videomed SRL ( a Baxter Healthcare Corp Company) | LLZ | Class II | |
| K254104 | ResScan Essentials | ResMed Corp | BZD | Class II | |
| K254102 | Glucommander | Glytec, LLC | NDC | Class II | |
| K254075 | Synapse Lung Nodule AI | FUJIFILM Corporation | OEB | Class II | |
| K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | SIA | Class II | |
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | GKZ | Class II | |
| K253130 | Dione PEEK Screw System | Zhejiang Decans Medical Devices Co.,Ltd. | MBI | Class II | |
| K252930 | AQUA Laminoplasty Systems | Zhejiang Decans Medical Devices Co.,Ltd. | NQW | Class II | |
| K260398 | LOGIQ e | GE Healthcare | IYN | Class II |