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 |
|---|---|---|---|---|---|
| K181217 | VesoFlow Lite DVT Compression Device | Caremed Supply, Inc. | JOW | Class II | |
| K181809 | GRYPHON® Anchors with DYNACORD™ Suture | Medos International SARL | MAI | Class II | |
| K181797 | Philips CT Big Bore Sliding Gantry Configuration | Phillips Medical Systems (Cleveland), Inc. | JAK | Class II | |
| K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions | Alcon Laboratories | LPL | Class II | |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) | Curiteva, Inc. | KWQ | Class II | |
| K181479 | Ingenia Ambition S and Ingenia Ambition X | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K181323 | Atlas Gold PTA Dilatation Catheter | C.R. Bard Inc | LIT | Class II | |
| K181237 | Glidesheath Slender Tibial Pedal Kit | Terumo Medical Corp. | DYB | Class II | |
| K181219 | OptiPillows EPAP Mask | Cpapnea Medical Supply | LWF | Class I | |
| K181197 | PHMB Foam Wound Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | Zenith Technical Innovations, LLC | IRP | Class II | |
| K181146 | ASK System | L&K Biomed Co.,Ltd. | JWH | Class II | |
| K180907 | HORIZON TMS Therapy System | Magstim Inc. | OBP | Class II | |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | HIG | Class II | |
| K180777 | K2M Expandable Interbody System | K2M, Inc | MAX | Class II | |
| K180341 | FUJIFILM 600 Series Endoscope EG-600WR v2 | FUJIFILM Corporation | FDS | Class II | |
| K180155 | Arm Type Blood Pressure Monitor | Avita Corporation | DXN | Class II | |
| K173461 | ECG recorder and Arrhythmia Detector | Smart Solutions Technologies SL | DSH | Class II | |
| K172280 | BH Sterilization Pouch | BH Medical Products Co., Ltd | FRG | Class II | |
| K171435 | VirtuOst Vertebral Fracture Assessment | O.N. Diagnostics, LLC | LLZ | Class II | |
| K163578 | EasyTouch Safety Pen Needle | MHC Medical Products | FMI | Class II | |
| K181830 | Azurion R2.0 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K181804 | Alphenix, INFX-8000C/B, V8.0 | Canon Medical Systems Corporation | OWB | Class II | |
| K181562 | Curiteva Anterior Cervical Plate System | Curiteva, Inc. | KWQ | Class II | |
| K181432 | ProVectra 3D Prime with VistaSoft | Durr Dental SE | OAS | Class II | |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | Medtronic Navigation, Inc | GEI | Class II | |
| K181182 | DYNACORD Suture | Medos International SARL | GAT | Class II | |
| K181094 | Polydioxanone Surgical Scaffold | Lntegra Lifesciences | FTL | Class II | |
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | Cianna Medical, Inc. | NEU | Class II | |
| K180150 | PL8 Wrist Reconstruction Plate | Citieffe Inc. | HRS | Class II | |
| K173923 | Temporary Cardiac Pacing Wire | Ethicon, Inc | LDF | Class II | |
| K173869 | Med-link Reusable Blood Pressure Cuff | Shenzhen Med-Link Electronics Tech Co.,Ltd | DXQ | Class II | |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | MRZ | Class II | |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | BZE | Class II | |
| K171977 | miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer | Hinacom Software and Technology, Ltd. | LLZ | Class II | |
| K171547 | Qualisys Clinical System | Qualisys AB | LXJ | Class II | |
| K181772 | NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) | Ceterix Orthopaedics, Inc. | GAT | Class II | |
| K181749 | SuperCable® Iso-Elastic™ Cerclage System | Kinamed, Incorporated | JDQ | Class II | |
| K181666 | Smart One | Mir - Medical International Research S.p.A. | BZH | Class II | |
| K181480 | MMD Tip | Strata Skin Sciences, Inc. | GEX | Class II | |
| K180770 | Propeller Sensor for Neohaler | Reciprocal Labs Corporation | CAF | Class II | |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) | Church & Dwight Co., Inc. | NUC | Class II | |
| K180737 | Ultrasound Scanner System bk2300 | BK Medical ApS | IYN | Class II | |
| K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH & Co. | EIH | Class II | |
| K180647 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K181708 | MTS Plazomicin 0.016-256 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K181422 | SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit | SPR Therapeutics, Inc | NHI | Class II | |
| K181272 | Picocare Family | WONTECH Co., Ltd. | GEX | Class II | |
| K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | 3M Healthcare | FXX | Class II | |
| DEN180008 | MolecuLight i:X | Moleculight Corp | QCR | Class I |