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 |
|---|---|---|---|---|---|
| K191640 | TK Intravascular Administration Set | Anhui Tiankang Medical Technology Co., Ltd. | FPA | Class II | |
| K201979 | Cervical Plate System | Eminent Spine | KWQ | Class II | |
| K201772 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder | Orthosensor, Inc. | ONN | Class II | |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA | Kitazato Corporation | MQL | Class II | |
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co.,Ltd | FLL | Class II | |
| K192809 | Dental Handpiece | Micro-NX Co., Ltd. | EFA | Class I | |
| K192464 | Injection Pen Needle | Gangan Medical Technology Jiangsu Co., Ltd. | FMI | Class II | |
| K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex LLC | KTT | Class II | |
| K200695 | MATRx plus | Zephyr Sleep Technologies | MNR | Class II | |
| K193364 | Intimate Rose Kegel Exercise System | Plus EV Holdings dba Intimate Rose | HIR | Class II | |
| K192380 | St Aia-Pack Bnp | Fujirebio Diagnostics, Inc. | NBC | Class II | |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | DiaSorin Molecular LLC | OCC | Class II | |
| K202116 | EzDent-i/ E2/ Prora View/ Smart M Viewer | Ewoosoft Co., Ltd | LLZ | Class II | |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories | MVN | Class II | |
| K201749 | Arthrex SwiveLock Anchor | Arthrex GmbH | MAI | Class II | |
| K201693 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K201513 | Quantra QPlus System | Hemosonics, LLC | QFR | Class II | |
| K201056 | NeuroBlate System | Monteris Medical Corp | GEX | Class II | |
| K200957 | Brainsway Deep TMS System | Brainsway Ltd. | QMD | Class II | |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | HET | Class II | |
| K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. | EMA | Class II | |
| K193201 | Btl-785F | Btl | GEI | Class II | |
| K202130 | FUJIFILM Video Laparoscope | FUJIFILM Corporation | GCJ | Class II | |
| K201636 | Hercules Suture Anchor System | In2bones USA, LLC | MBI | Class II | |
| K200939 | Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | |
| K200586 | Straumann TLX Implant System | Straumann USA, LLC | DZE | Class II | |
| K200093 | Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug | Anhui Lntco Medical Products Co., Ltd. | LZA | Class I | |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. | HIS | Class II | |
| K193318 | Distinct® Early Detection Pregnancy Test | Acon Laboratories, Inc. | LCX | Class II | |
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | PTD | Class II | |
| K202050 | Cranial 4Pi Immobilization | Brainlab, Inc. | IYE | Class II | |
| K201995 | CUBEScan BioCon-1100 | MCUBE TECHNOLOGY Co.,Ltd. | IYO | Class II | |
| K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement | Medtronic, Inc. | PML | Class II | |
| K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co. Ltd. | DQA | Class II | |
| K201137 | Asept Surgical Face Mask | PFM Medical GmbH | FXX | Class II | |
| K200597 | Straumann BLX Gold Abutments | Straumann USA, LLC (on Behalf of Institut Straumann AG) | NHA | Class II | |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona Inc | PNP | Class II | |
| K200033 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory Co. | GGP | Class II | |
| K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | Penumbra Inc. | QEW | Class II | |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NLQ | Unclassified | |
| K193537 | Omnichroma Flow | Tokuyama Dental Corporation | EBF | Class II | |
| K193476 | VariLymph 12 pro | Slk Medical GmbH | JOW | Class II | |
| K192275 | invisa-RED ELITE | IR Technology, LLC | OLI | Class II | |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Devicor Medical Products Inc | KNW | Class II | |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental Inc. | DZE | Class II | |
| K192723 | Coloring Liquid | Aidite (Qinhuangdao) Technology Co., Ltd | EIH | Class II | |
| K191591 | BB Base 3D printing resin for denture base | Enlighten Materials Co., Ltd. | EBI | Class II | |
| K190600 | ORION Spinal System | Orion Biotech, Inc. | NKB | Class II | |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | Karl Storz Endoscopy-America, Inc. | OWN | Class II |