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 |
|---|---|---|---|---|---|
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | GEH | Class II | |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | ORZ | Class II | |
| K242773 | Electro Lube NXT | STERIS Corporation | GEI | Class II | |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K250823 | Any-Com Flow | Mediclus Co., Ltd | EBF | Class II | |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) | Advanced Sterilization Products | MLR | Class II | |
| K250402 | AVAVA™ Skin Treatment System | Avava, Inc. | ONG | Class II | |
| K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated | LLZ | Class II | |
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) | Neuralynx, Inc. | GYC | Class II | |
| K243852 | Elfor-L | Elfi-Tech, Ltd. | DPW | Class II | |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd | EIH | Class II | |
| K250748 | Klaxon (Twist); Klaxon (Twist R) | Klaxon-Mobility GmbH | ITI | Class II | |
| K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | HHW | Class II | |
| K250416 | GBrain MRI | Galileo Cds, Inc. | QIH | Class II | |
| K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona Inc | NHA | Class II | |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | EBZ | Class II | |
| K243898 | Chlorine Sentinel II | Nelson Environmental Technologies, Inc. | MSY | Class II | |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | MEDLINE INDUSTRIES, LP - Northfield | JDR | Class II | |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd | FGB | Class II | |
| K243710 | Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd | FED | Class II | |
| K243558 | Canvas Dx | Cognoa, Inc. | QPF | Class II | |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed, Ltd. | NDN | Class II | |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | EBI | Class II | |
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems Inc | QWR | Class II | |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | FUJIFILM Corporation | FET | Class II | |
| K243044 | Alma Harmony | Alma Lasers Ltd. | GEX | Class II | |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | HIF | Class II | |
| K242748 | Oncospace | Oncospace, Inc. | MUJ | Class II | |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | EBW | Class I | |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | MYN | Class II | |
| K242120 | Otoplan | Cascination | QQE | Class II | |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | Shenzhen Vivolight Medical Device&technology Co., Ltd. | NQQ | Class II | |
| DEN240064 | CT-132 | Click Therapeutics, Inc. | SEE | Class II | |
| K250754 | cmAngio® (V1.6) | Curemetrix, Inc. | QIH | Class II | |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | KWQ | Class II | |
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | KNT | Class II | |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | GXH | Class II | |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K250112 | FitboneTM Trochanteric | Orthofix SRL | HSB | Class II | |
| K250058 | Neat 001 | Brain Electrophysiology Laboratory Company, LLC | OLZ | Class II | |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | EBZ | Class II | |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus Inc. | LPL | Class II | |
| K243943 | TriMed® Compression Screws | Trimed Inc | HWC | Class II | |
| K243240 | Vitrea CT VScore | Canon Medical Informatics, Inc. | JAK | Class II | |
| K243145 | syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. | QAS | Class II | |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | OVE | Class II | |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co., Ltd. | MQL | Class II | |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | MQL | Class II | |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | LPH | Class II | |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Integra LifeSciences Corporation | GWG | Class II |