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 |
|---|---|---|---|---|---|
| K243233 | esolution® Esophageal Retractor | S4 Medical Corp | QXU | Class II | |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies, Inc | PLF | Class II | |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) | STERIS Corporation | ODC | Class II | |
| K243004 | Xpine Spinal Fixation System | Jeil Medical Corporation | NKB | Class II | |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | NGL | Class II | |
| K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) | Pulnovo Medical (Wuxi) Co., Ltd. | DYB | Class II | |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | KLE | Class II | |
| K242382 | décoLITE LED Device | iSMART Developments, Ltd. | OHS | Class II | |
| K242286 | Superflow Prime Treatment System (ASP-1M) | Guangzhou Aimira Innovation Technology Co, Ltd. | GEI | Class II | |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K241802 | Device 300397 Putty | Geistlich Pharma AG | MQV | Class II | |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | LPH | Class II | |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | KPS | Class II | |
| K241342 | Hair Growth Comb (SZ-23,SZ-23A) | Shenzhen Nuon Medical Equipment Co., Ltd. | OAP | Class II | |
| K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | GEI | Class II | |
| K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | MLO | Class II | |
| K240510 | Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K240417 | ProFound Detection (V4.0) | iCAD, Inc. | QDQ | Class II | |
| K242734 | ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System | Zsfab Inc | ODP | Class II | |
| K242702 | VioSeal | Spident Co., Ltd. | KIF | Class II | |
| K242595 | Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) | Shenzhen Greatro Electronic Technology Co., Ltd. | OHT | Class II | |
| K242379 | LL Implant System | Ossvis Co., Ltd. | DZE | Class II | |
| K242373 | Mako Shoulder Application (1.0) | Mako Surgical Corp. | OLO | Class II | |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | BioFire Diagnostics, LLC | PCH | Class II | |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Howmedica Osteonics Corp | KWQ | Class II | |
| K241872 | Remanufactured EndoWrist ProGrasp Forceps (420093) | Rebotix | QSM | Class II | |
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | JAQ | Class II | |
| K241719 | NeuroICH | Neurocareai, Inc. | QAS | Class II | |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group | MQP | Class II | |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc | MQB | Class II | |
| K240712 | icobrain aria | icometrix | QBS | Class II | |
| K240429 | Trilogy Tissue Marker | Inrad | NEU | Class II | |
| K240415 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | |
| K212425 | MicroTrend System | Exostat Medical, Inc. | CCK | Class II | |
| K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) | Biofire Diagnostics, LLC (Biomerieux) | QDS | Class II | |
| K242803 | Compound W Skin Tag Remover | MedTech Products, Inc. | GEH | Class II | |
| K242719 | Elexir 2.0 (Allive3) | NU Eyne Co., Ltd. | PCC | Class II | |
| K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | MBH | Class II | |
| K242261 | Accelx Implant System | Biotech Dental | DZE | Class II | |
| K242039 | Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | Abbott Medical | DQX | Class II | |
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | GCJ | Class II | |
| K240450 | Citrepore™ | Acuitive Technologies | MQV | Class II | |
| K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | KWQ | Class II | |
| K242947 | FreedomFlow™ Orbital Circumferential Atherectomy System | Cardio Flow, Inc. | MCW | Class II | |
| K242664 | gentleheel® Adult Incision Device | GRI-Alleset, Inc. | FMK | Class II | |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | GWF | Class II | |
| K242340 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) | Shenzhen Kentro Medical Electronics Co., Ltd | NUH | Class II |