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 |
|---|---|---|---|---|---|
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | Orthopediatrics Corp | HRS | Class II | |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | LZO | Class II | |
| K190502 | ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co., Ltd | PNR | Class II | |
| K183458 | exoplan 2.3 | Exocad GmbH | LLZ | Class II | |
| K183387 | M3290B Patient Information Center iX | Philips North America LLC | MHX | Class II | |
| K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | KRD | Class II | |
| K191877 | FLUOROspeed | Shimadzu Corp. | JAA | Class II | |
| K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K191496 | TDS Standard Solution | Mesa Laboratories Inc | FKH | Class II | |
| K191262 | aBSI | Exini Diagnostics AB | LLZ | Class II | |
| K191225 | EEG Electrode Template | Rhythmlink International, LLC | GXY | Class II | |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K191033 | LunaGuard Nighttime Dental Protector | McKeon Products, Inc. | OBR | Unclassified | |
| K190399 | Beddr 200 System | Hancock Medical, Inc. | DQA | Class II | |
| K183323 | UPJ Occlusion Balloon Catheter | Cook Incorporated | EYB | Class II | |
| K183305 | Crossing Support Catheter | Tractus Vascular, LLC | DQY | Class II | |
| K191813 | MobileDiagnost wDR 2.2 | Sedecal S.A. | IZL | Class II | |
| K191741 | Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape | Intertape Polymer Inc. | JOJ | Class II | |
| K191602 | APA Oxy Blade | Venner Medical (Singapore) Pte Ltd | CCW | Class I | |
| K191546 | Epicardial Access System | Baylis Medical Co., Inc. | DYB | Class II | |
| K191505 | Rezum System | Nxthera (A Boston Scientific Company) | KNS | Class II | |
| K191321 | Primelase Excellence | High Technology Products, SLU | GEX | Class II | |
| K191217 | Jazz Pf | Implanet | OWI | Class II | |
| K191143 | PowerFlow Implantable Apheresis IV Port | C.R. Bard Inc | PTD | Class II | |
| K190338 | 046 Zenith Flex | Inneuroco, Inc. | NRY | Class II | |
| K190293 | Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. | BTG | Class II | |
| K190090 | DynoSense Vital Sign Measuring System | Dynosense Corp. | MWI | Class II | |
| K183112 | DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) | Lumendi, LLC | GEI | Class II | |
| K183091 | Elaris Pedicle Screw System | Spinewelding AG | NKB | Class II | |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics, Ltd. | GGT | Class II | |
| K181216 | Hamilton-T1, Hamilton-C1 | Hamilton Medical AG | CBK | Class II | |
| K181154 | Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor | Shenzhen Med-Link Electronics Tech Co.,Ltd | DXN | Class II | |
| K191559 | AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM | United States Endoscopy Group, Inc. | FEQ | Class II | |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co.,Ltd | MRG | Class II | |
| K191469 | Biotronik Stylets | BIOTRONIK AG | DRB | Class II | |
| K191267 | ImagingRing System on Rails | Medphoton GmbH | IYE | Class II | |
| K191214 | JO Premium Jelly Original Personal Lubricant | United Consortium | NUC | Class II | |
| K191192 | SurgTech GENOLL Total Knee System | Surgtech, Inc. | JWH | Class II | |
| K191190 | Steerable Introducer | Freudenberg Medical, LLC | DYB | Class II | |
| K190887 | Leksell Vantage Stereotactic System | Elekta Instrument AB | HAW | Class II | |
| K190176 | Minamo | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K183590 | Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip | Olympus Medical Systems Corp. | PKL | Class II | |
| K183193 | MREplus+ Software | Resoundant, Inc. | LLZ | Class II | |
| K182871 | Mini TENS Therapy Device | Shenzhen Jumper Medical Equipment Co.,Ltd. | NUH | Class II | |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | AAP Implantate AG | HRS | Class II | |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | Hardy Diagnostics | JTN | Class II | |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories | LPN | Class II | |
| K191773 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | OWT | Class II | |
| K191764 | Inion BioRestore | Inion Oy | MQV | Class II | |
| K191761 | Mobius3D | Varian Medical Systems, Inc. | IYE | Class II |