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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K172971 | Bmls16-1 | BioMedical Life Systems Inc. | NUH | Class II | |
| K181509 | Endorate Valve Sets | Smartdata Suzhou Co., Ltd | OCX | Class II | |
| K181499 | DRI Cocaine Metabolite Assay | Microgenics Corporation | DIO | Class II | |
| K181350 | ASTRA-OCT Spine System | Spinecraft LLC | NKG | Class II | |
| K181327 | InPen Dose Calculator | Companion Medical, Inc. | NDC | Class II | |
| K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical | NKB | Class II | |
| K181092 | CHROMID CARBA agar (CARB) | bioMerieux, Inc. | JSO | Class II | |
| K180868 | Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set | Cook Ireland Ltd. | FGE | Class II | |
| K180755 | Vail ALIF Buttress Plate System | Evolution Spine, LLC | KWQ | Class II | |
| K180590 | Tyber Medical PT Interbody Spacer System | Tyber Medical | ODP | Class II | |
| K180515 | GammaTile | Isoray Medical, Inc. | KXK | Class II | |
| K173970 | Materialise PKA Guide System | Materialise N.V. | HSX | Class II | |
| K173927 | Elecsys BRAHMS PCT | Roche Diagnostics GmbH | PRI | Class II | |
| K173776 | BIOLOX delta Option and Extra-long Heads | Microport Orthopedics Inc. | LZO | Class II | |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical Inc. | GCA | Class II | |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | Ethicon, Inc | PWJ | Class II | |
| K172694 | Sterile Disposable Syringes | Shenyang Mastech Medical Device Co., Ltd. | DXT | Class II | |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel | BioFire Diagnostics, LLC | PEN | Class II | |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. | NIE | Class II | |
| K181044 | 400um Perforator and Accessory Vein Ablation Kit | Boston Scientific Corporation | GEX | Class II | |
| K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | KGE | Class II | |
| K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical, Inc. | NAY | Class II | |
| K173359 | Fractional CO2 Surgical Laser System | Ami, Inc. | GEX | Class II | |
| K173277 | ASAHI PTCA Guide Wire ASAHI SION black | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K172778 | CheckMyHeart Plus | Dailycare Biomedical, Inc. | DPS | Class II | |
| K161085 | Nitrile Patient Examination Powder Free Glove, Textured, Black | Multisafe Sdn Bhd | LZA | Class I | |
| K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQY | Class II | |
| K180705 | Riptide Aspiration System React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | |
| K181526 | XRpad2 4343 HWC-M Flat Panel Detector | Varex Imaging Corporation | MQB | Class II | |
| K181193 | PeriView FLEX | Olympus Surgical Technologies America | KTI | Class II | |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | bioMerieux, Inc. | JWY | Class II | |
| K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd | FGB | Class II | |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | PENTAX of America, Inc. | PEA | Class II | |
| K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. | EBF | Class II | |
| K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | Ethicon, Inc | FTL | Class II | |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, LLC | OLV | Class II | |
| K173864 | Peekplus® Interbody Fusion Device | Vallum Corporation | MAX | Class II | |
| K173276 | Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | OLU | Class II | |
| K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | DZE | Class II | |
| K181410 | MotoCLIP/HiMAX Implant System | Crossroads Extremity Systems LLC | JDR | Class II | |
| K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | Largan Medical Co., Ltd. | LPL | Class II | |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | PGM | Class II | |
| K180481 | Servator B SALF Solution | S.A.L.F. SpA | KDN | Class II | |
| K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | JOW | Class II | |
| K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | KGE | Class II | |
| K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | OLO | Class II | |
| K180021 | Proton Positioing and Immobilization Devices | Medtec Inc dba Civco Medical Solutions and Civco Radiotherap | IYE | Class II | |
| K173815 | Allergan Botox Needle Electrode | Natus Manufacturing Limited | IKT | Class II | |
| K173164 | Ecolab POU Water Filter | Microtek Medical LLC | NHV | Class II |