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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K152273 | Cosmedico Ultraviolet Lamps of Various Models | Cosmedico Light, Inc. | LEJ | Class II | |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | Advanced Brain Monitoring, Inc. | OMC | Class II | |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | JDQ | Class II | |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed LLC | HRS | Class II | |
| K151788 | Cardinal Health Sterilization Wrap | Cardinal Health200, LLC | FRG | Class II | |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. | KLE | Class II | |
| K151531 | MasterLoc Stem | Medacta International SA | LZO | Class II | |
| K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips North America LLC | DXJ | Class II | |
| K151283 | Lung Analysis Software | Canon Medical Informatics, Inc. | JAK | Class II | |
| K151109 | Lumenis Smart532 Laser System | Lumenis Ltd | GEX | Class II | |
| K150595 | SCENARIA Phase 3 Whole-body X-ray CT System | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K150462 | Vera | Reflexion Health, Inc. | LXJ | Class II | |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | ZOLL Circulation, Inc. | NCX | Class II | |
| K143420 | SYMBIS Surgical System | Imris, Inc. | HAW | Class II | |
| K142410 | Elliquence Electrodes | Elliquence LLC | GEI | Class II | |
| K152675 | Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter | Baxter Healthcare Corporation | KDJ | Class II | |
| K152605 | Impulse Angiographic Catheter, Expo Angiographic Catheter | Boston Scientific Corporation | DQO | Class II | |
| K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System | Ascension Orthopedics, Inc. | HWC | Class II | |
| K152468 | Reusable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | DXQ | Class II | |
| K152465 | Disposable Blood Pressure Cuff | Shenzhen Vistar Medical Supplies Co., Ltd. | DXQ | Class II | |
| K152367 | Optiflux dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K152159 | Oravan Herbst | Oravanosa, LLC | LRK | Class II | |
| K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | Baxter Healthcare Corporation | KDJ | Class II | |
| K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | NQQ | Class II | |
| K152008 | Physica PS Knee System | Lima Corporate S.p.A. | JWH | Class II | |
| K151971 | STERRAD CYCLESURE 24 Biological Indicator | Advanced Sterilization Products | FRC | Class II | |
| K151894 | IPS Ivocolor | Ivoclar Vivadent, Inc. | EIH | Class II | |
| K151875 | Pavati Zirconia | Ccri, Inc. | EIH | Class II | |
| K151758 | ALAR Nasal Valve Stent | Medtronic Xomed, Inc. | GAT | Class II | |
| K151718 | iFuse Implant System | SI-Bone, Inc. | OUR | Class II | |
| K151715 | T3 Software | Etiometry Inc. | MWI | Class II | |
| K151456 | Small Bone Nail Implant | Vilex LLC | HSB | Class II | |
| K151159 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | IWB | Class II | |
| K150568 | ARROW Humeral stems size 6 and 16 | Fournitures Hospitalieres Industrie | PHX | Class II | |
| K150523 | AVAmax Vertebral Balloon | Care Fusion | HRX | Class II | |
| K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family | PENTAX of America, Inc. | EOQ | Class II | |
| K143716 | DSM Biomedical DPR Cable | DSM Biomedical, Inc. | JDQ | Class II | |
| K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | RESORBA Medical GmbH | GAW | Class II | |
| K143117 | Wire Sterilization Package with Indicators | American Orthodontics | FRG | Class II | |
| K141854 | Instrument Cassette (Efccl1-F) | Osung MND Co., Ltd. | KCT | Class II | |
| K152795 | RiverLon (Nylon) Suture | Riverpoint Medical, LLC | GAR | Class II | |
| K152338 | VERTEX(r) Reconstruction System | Medtronic Sofamor Danek USA Inc | NKG | Class II | |
| K152315 | JOURNEY II Uni Tibial Base and Insert | Smith & Nephew, Inc. | HSX | Class II | |
| K152204 | VS3-IR system | Visionsense, Ltd. | OWN | Class II | |
| K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | MWI | Class II | |
| K152095 | Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) | Cosmedico Light, Inc. | LEJ | Class II | |
| K152039 | Genesys Spine TiLock2 Spinal System | Genesys Spine | NKB | Class II | |
| K151723 | Rainbow Trans | GENOSS Co., Ltd. | EIH | Class II | |
| K151535 | Cavex Cream Alginate | Cavex Holland B.V. | ELW | Class II |