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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | Bozhou Rongjian Medical Appliance Co., Ltd. | GZJ | Class II | |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | Stryker Sustainability Solutions | GEI | Class II | |
| K220416 | SwiftMR | AIRS Medical Inc. | LLZ | Class II | |
| K220350 | KardiaMobile 6L | AliveCor | DXH | Class II | |
| K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions Ltd | DZE | Class II | |
| K220083 | LDV((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | QNQ | Class II | |
| K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FED | Class II | |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | Stryker Corp. | GCJ | Class II | |
| K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | |
| K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | OLP | Class II | |
| K211953 | Disposable Sterilized Latex Surgical Gloves | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | KGO | Class I | |
| K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | Apyx Medical Corporation (Formerly Bovie Medical Corporation | GEI | Class II | |
| K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | FMI | Class II | |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Innovative Health, LLC. | OWQ | Class II | |
| K203661 | CRYO Arctic, CRYO Penguin | Cryoscience North America, Inc. | MLY | Unclassified | |
| K202920 | OptiComp | Pac-Dent Inc. | EBF | Class II | |
| K201393 | restor3d MTP Implant | restor3d, Inc. | KWD | Class II | |
| K221215 | e-motion M25 | Alber GmbH | ITI | Class II | |
| K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | LXC | Unclassified | |
| K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International SA | QSR | Class II | |
| K220191 | Disposable Face Mask | Jiujiang Taixin Technology Co., Ltd. | FXX | Class II | |
| K213659 | LigaPASS™ 2.0 Ligament Augmentation System | Medicrea International | OWI | Class II | |
| K213481 | Medline General Surgery Tray | MEDLINE INDUSTRIES, LP - Northfield | LRO | Class II | |
| K213191 | S-Line | Barkey GmbH & Co. KG | LGZ | Class II | |
| K212327 | M-Vizion Monobloc | Medacta International SA | LZO | Class II | |
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | LPH | Class II | |
| DEN200062 | Parsortix PC1 Device | Angle Europe, Ltd. | QSA | Class II | |
| K221000 | On3d | 3D Ons, Inc. | LLZ | Class II | |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | OWY | Class II | |
| K220564 | 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 | 3M Company | JOJ | Class II | |
| K220532 | Disposable surgical mask | Xiamen Blue Star Enterprise Co., Ltd. | FXX | Class II | |
| K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | 3M Company | PZW | Class II | |
| K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | DQD | Class II | |
| K220155 | Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs | Motex Healthcare (Anhui) Co., Ltd. | LZA | Class I | |
| K213829 | SCENARIA View | Fujifilm Healthcare Corporation | JAK | Class II | |
| K213402 | Triever24, Triever20 | Inari Medical, Inc. | QEW | Class II | |
| K212988 | ONO Retrieval Device | Onocor Vascular, LLC | MMX | Class II | |
| K212803 | DailyMate Orthodontic Aligner System | 3D Global Biotech Inc. | NXC | Class II | |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | KIF | Class II | |
| K211878 | LiquiBand XL | Advanced Medical Solutions Limited | OMD | Class II | |
| K211810 | Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) | Pt. Shamrock Manufacturing Corpora | LZA | Class I | |
| K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | PZI | Class II | |
| K220838 | Artisan Bone Plug, Universal Cement Restrictor | Howmedica Osteonics, dba Stryker Orthopaedics | LZN | Class II | |
| K220832 | syngo Dynamics (Version VA40E) | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K220656 | iovera System | Pacira Biosciences, Inc. | GXH | Class II | |
| K220522 | 7D Surgical System - Percutaneous Application (7D Flash Frame) | 7D Surgical, Inc. | OLO | Class II | |
| K220381 | Diode Laser Therapy Systems | Beijing Lasertell Medical Co., Ltd. | GEX | Class II | |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | Spectrum Medical Inc | DWF | Class II | |
| K212979 | CalcShift™ Displacement Calcaneal Osteotomy System | Medartis AG | HRS | Class II | |
| K212752 | Med-link Pulse Oximeter | Shenzhen Med-Link Electronics Tech Co.,Ltd | DQA | Class II |