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 |
|---|---|---|---|---|---|
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic, Inc. | QJI | Class II | |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker Corp. | HSB | Class II | |
| K253282 | ZSmile System | Dror Orthodesign | NXC | Class II | |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | EHD | Class II | |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | DRT | Class II | |
| K252438 | Explant Express | Applied Medical Technology Inc | QVS | Class II | |
| K252087 | Navigation Module of the Cortium® System | ulrich medical USA Inc | OLO | Class II | |
| K252048 | 808nm semiconductor laser hair removal machine | Xi'An Taibo Electronic Technology Co., Ltd. | GEX | Class II | |
| K250644 | MSS - Monobloc stem | Medacta International SA | PHX | Class II | |
| K252649 | Tap2d | Nano-X Imaging Ltd | IZF | Class II | |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | DZE | Class II | |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | MOF | Class II | |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | FRO | Unclassified | |
| K251200 | Vital Signs | Oxehealth Ltd | QME | Class II | |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd | DQX | Class II | |
| K254305 | BAROguard Donor Lung Preservation System | Paragonix Technologies Inc. | KDN | Class II | |
| K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | GEI | Class II | |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHS | Class II | |
| K253671 | Dual Stage Venous Cannulae | Corcym Inc. | DWF | Class II | |
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | GQG | Class I | |
| K252457 | Disposable Distal End Tape Hood | Shanghai Seegen Photoelectric Technology Co., Ltd | FDF | Class II | |
| K251981 | Boston PICO (Boston PICO) | Boston Aesthetics Inc | GEX | Class II | |
| K251769 | RevealAI-Lung | Precision Medical Ventures, Inc. dba Revealdx | POK | Class II | |
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | EBW | Class I | |
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | SCL | Class II | |
| K253763 | Y-Knotless™ Flex Anchors | ConMed Corporation | MBI | Class II | |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | IOR | Class I | |
| K253611 | Falco Fusion System | McNicoll Surgical, Inc. | OUR | Class II | |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K252684 | Labcorp Fentanyl Urine Visual Test | MEDTOX Diagnostics, Inc. | DJG | Class II | |
| K252496 | Neurophet AQUA AD Plus | Neurophet, Inc. | QIH | Class II | |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | INI | Class II | |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | INI | Class II | |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | INI | Class II | |
| K252091 | Surgical Reality Viewer | Medicalvr BV | QIH | Class II | |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | GCJ | Class II | |
| K251427 | Ek Multi Angled 30 Abutment | Hiossen, Inc. | NHA | Class II | |
| K251354 | UV Smart D60 | UV Smart Technologies B.V. | SCS | Class II | |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits | HR Healthcare | EZD | Class II | |
| K243732 | Multi-Unit DAS System | Talladium Espana, SL | NHA | Class II | |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | MBI | Class II | |
| K253842 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp. | LYK | Class II | |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | DRT | Class II | |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S. - Electro Medical Systems SA | ELC | Class II | |
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | Impedimed, Inc. | OBH | Class II | |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 4Web Medical, Inc. | OUR | Class II | |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K252164 | NorthStar™ Mapping System | Imricor Medical Systems | DQK | Class II | |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | Koru Medical Systems, Inc. | FRN | Class II |