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 |
|---|---|---|---|---|---|
| K131295 | Nio Color 3Mp LED | Barco N.V. | LLZ | Class II | |
| K131225 | Adroit Guiding Catheter | Cordis Corp., A Johnson & Johnson Co. | DQY | Class II | |
| K131121 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Corporation | DXN | Class II | |
| K131045 | Enterprise ECG Analysis / Interpretation Software | Cardiac Designs, LLC | DQK | Class II | |
| K130411 | 740 Select | Cas Medical Systems, Inc. | MWI | Class II | |
| K130354 | Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair) | Entrigue Surgical, Inc. | LYA | Class I | |
| K130297 | Scanora 3Dx | Palodex Group Oy | OAS | Class II | |
| K130288 | Stealth Monitor, Stealth Docking Cable, Stealth Display and Storage Device | Cardiac Insight, Inc. | DSH | Class II | |
| K130278 | Mr Permeability | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K130170 | Exspiron 1Xi | Respiratory Motion, Inc. | BZK | Class II | |
| K124056 | Frend Psa Plus (Reagent Cartridge) | Nanoentek Inc | LTJ | Class II | |
| K123041 | Vasostat Hemostasis Device | Forge Medical, Inc. | DXC | Class II | |
| K130343 | Corin Trinity Acetabular System with Extra-Long Heads | Corin USA | LZO | Class II | |
| K123801 | Finger Pulse Oximeter | Shenzhen Kingyield Technology Co., Ltd | DQA | Class II | |
| K123034 | Vital Sutures Suturex Cirugia Peruana Sutumed | Unilene, Sac | GAR | Class II | |
| K131246 | Coronis 3Mp | Barco N.V. | LLZ | Class II | |
| K131209 | Terason Usmart3200t Ultrasound System | Teratech Corp. | IYN | Class II | |
| K131156 | Lanx Spinal Fixation System | Lanx, Inc. | KWP | Class II | |
| K131088 | Portable Digital Color Doppler Ultrasound System | Sonoscape Company Limited | IYN | Class II | |
| K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K130984 | Profemur Renaissance Classic Hip Stem | Wrightmedicaltechnologyinc | LZO | Class II | |
| K130917 | Healix Advance Knotless Br Anchor | DePuy Mitek, Inc. | MAI | Class II | |
| K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | Medtronic, Inc. | LIT | Class II | |
| K130634 | Corin Metafix Hip Stem | Corin USA | LZO | Class II | |
| K130559 | Mobicath Bi-Directional Guiding Sheath | Great Batch Medical | DYB | Class II | |
| K130481 | Sleepweaver Anew Full Face Soft Cloth Pap Mask | Circadiance | BZD | Class II | |
| K130184 | Zenolux | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | |
| K123925 | Mtm Clear Aligner in-Office | Dentsply International, Inc. | NXC | Class II | |
| K123855 | Water-Filled Teether | Solid Toys Ind. Ltd. | KKO | Class II | |
| K123746 | Ames Therapy Device | Ames Technology, Inc. | IKK | Class II | |
| K123692 | Pipeline Knee System | Pipeline Orthopedics | JWH | Class II | |
| K123619 | Intrablock Bioball Hip System (Ibs) | Merete GmbH | LZO | Class II | |
| K123569 | Antegrade Femoral Nail | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | |
| K122801 | Providence Cervical Cage | Providence Medical Technology, Inc. | ODP | Class II | |
| K122639 | Synthes Syncage Evolution Spacer | Synthes (USA) Products LLC | MAX | Class II | |
| K121898 | Stay Fresh Skin Fold Management Textile | Quick-Med Technologies, Inc. | FRL | Class I | |
| K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device | Polymed Therapeutics, Inc. | DKZ | Class II | |
| K130430 | Ivas 10Mm and 15Mm Balloon Catheter | Stryker Corp. | HRX | Class II | |
| K130115 | Discovery Mr750w 3.0T | GE Healthcare | LNH | Class II | |
| K123937 | Atom Transcapsule V-707 | Atom Medical Corporation | FPL | Class II | |
| K123084 | Disposable High Pressure Stopcock/manifold Model Hp Stopcock, Mp Stopcock, Hp Manifold, Php Manifold | Elcam Medical A.C.A.L. | FMG | Class II | |
| K122978 | Saniclave 102, Model Rs-Sc-102 | Alternative Pioneering Research and Development | FLE | Class II | |
| DEN130002 | Tina-Quant Hba1c Gen. 2 Test System | Roche Diagnostics GmbH | PDJ | Class II | |
| K131299 | Anythink Pacs Workstation | Beijing Crealife Technology Co., Ltd. | LLZ | Class II | |
| K130804 | Uromax Ultra Balloon Dilatation Catheter | Boston Scientific Corporation | EZN | Class II | |
| K130551 | Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel | Centers for Disease Control and Prevention | OQW | Class II | |
| K130538 | Winx Sleep Therapy System | Apnicure, Inc. | OZR | Class II | |
| K130524 | Breathid Hp System | Meridian Bioscience Israel Ltd. | MSQ | Class I | |
| K130444 | H-30 Holmium Laser System | Cook Inc. | GEX | Class II | |
| K123662 | The Justright Surgical Vessel Sealing System | Bolder Surgical, LLC | GEI | Class II |