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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | LON | Class II | |
| K091763 | Michelangelo Bunion System - Mabs, Model: Ma6000 | Instratek, Inc. | HTN | Class II | |
| K091742 | Synchron Systems Enzymatic Creatinine (Cr-E) Reagent, Model A60298 | Siemens Healthcare Diagnostics Inc. | JFY | Class II | |
| K091461 | Bernoulli Management System, Oxinet III and Lifegard Vue | Cardiopulmonary Corp. | MOD | Class II | |
| K091455 | Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model Dz113c-X, Diazyme Liquid Stable Enzymatic Potassium Assay Cal | Diazyme Laboratories, Inc. | MZV | Class II | |
| K091288 | Medi-6000 Medical Image Digitizer | Microtek International, Inc. | LMA | Class II | |
| K091123 | Advia Centaur Dheas Master Curve Materials | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K090995 | B. Braun Contiplex Continuous Nerve Block Set | B.Braun Medical, Inc. | CAZ | Class II | |
| K090740 | Modification to: Tsrh Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K090332 | Assure Pro Blood Glucose Monitoring System, Model 46001 | Arkray Factory USA, Inc. | NBW | Class II | |
| K090048 | Asfora Bullet Cage System | Medical Designs, LLC | MAX | Class II | |
| K083758 | Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial, Mono, Bi- & Tripolar Nerve Stimulators | The Electrode Store | GXY | Class II | |
| K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | OOE | Class II | |
| K080564 | Scanscope Xt System | Leica Biosystems Imaging, Inc. | NOT | Class II | |
| K092108 | Truss Thoracolumbar Plate System | Globus Medical, Inc. | KWQ | Class II | |
| K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | NKB | Class II | |
| K091238 | Uni-Vent-731 Series Ventilators, Model 731Emv+ | ZOLL Medical Corporation | CBK | Class II | |
| K091059 | Foxq 980 Laser | A.R.C. Laser GmbH | GEX | Class II | |
| K090781 | Helio2 Blender | Precision Medical, Inc. | BZR | Class II | |
| K090774 | Lightlas Selector | Lightmed Corp. | HQF | Class II | |
| K090727 | Imm Dental Irrigation Tubing Set | Innovative Medical Manufacturing Co. | EBW | Class I | |
| K090571 | Alma Lasers Alex755 Module | Alma Lasers Ltd. | GEX | Class II | |
| K090337 | Tropazone Lotion | Midlothian Laboratories | FRO | Unclassified | |
| K083571 | Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color | Purna Bina Sdn Bhd | LYY | Class I | |
| K083382 | Chroma, Model: Rz153c | Scottcare Corporation | MWJ | Class II | |
| K081246 | Tt-102 | Tissue Technologies Holdings, LLC | FRO | Unclassified | |
| K080844 | G3 Generator and Accessories-Dissector Plasma Knife | Gyrus ACMI, Inc. | GEI | Class II | |
| K063461 | Anova Containment Device | Anova Corporation | EZX | Class II | |
| K092315 | Sorin Vvr 4000I and 4000I Smarxt Filtered Hardshell Venous Reservoir | Corcym Inc. | DTN | Class II | |
| K092223 | Modification to: Binaxnow Influenza a & B Test | Binax, Inc. | PSZ | Class II | |
| K092203 | Omnisure Urethral Sling, Model Otk52 | Mpathy Medical Devices, Ltd. | OTN | Class II | |
| K091970 | Aixplorer Ultrasound System | Supersonic Imagine | IYN | Class II | |
| K091552 | Switch Trt | Audifon GmbH & Co. KG | KLW | Class II | |
| K091453 | Lps Universal Tibial Hinge Inserts, Model 198727012-198727331 | Depuy Orthopaedics Inc. | KRO | Class II | |
| K091279 | Nipro Disposable Syringe | Nipro Medical Corporation | FMF | Class II | |
| K091230 | Hdr Prostate Template and Accessories | Photon Technologies Corporation | JAQ | Class II | |
| K090681 | Tanscu O2 | Electrochemical Oxygen Concepts | KPJ | Class II | |
| K090576 | Footprint Urinary Drainage Catheter | Footprint Medical Inc. | EZD | Class II | |
| K090551 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Tangshan Zhongpu Plastic Products Co., Ltd. | LYZ | Class I | |
| K083728 | Invision System | Inneroptic Technology, Inc. | IYO | Class II | |
| K092238 | Agfa Computed Radiography Systems with Dx-G Digitizers | AGFA Healthcare Corp. | MQB | Class II | |
| K091629 | Proteus 235 Proton Therapy System | Ion Beam Applications S.A. | LHN | Class II | |
| K091410 | Disposable EMG Needle Electrodes, Myoline, Myoline 2, Myobot, | Spes Medica S.P.A | IKT | Class II | |
| K090343 | Sentinel Spinal System | Life Spine | KWP | Class II | |
| K090342 | Polaris Pressure Adjustable Valve, Models Spv, Spva, Spvb, Spv-140, Spv-300, Spv-400 | Sophysa | JXG | Class II | |
| K090199 | Jiajian Acupuncture Needle | Wuxi Jiajian Medical Instrument Co., Ltd | MQX | Class II | |
| K091699 | Amsure Hydrophilic Latex Foley Catheter | Amsino International, Inc. | EZL | Class II | |
| K091521 | Powered Vinyl Patient Examination Gloves | Shijiazhuang Century Plastic Co., Ltd. | LYZ | Class I | |
| K091357 | Microcool Surgical Gown, Breathable High Performance Kc400 | Kimberly-Clark Corporation | FYA | Class II | |
| K091193 | Accell Evo3c | IsoTis OrthoBiologics, Inc. | MBP | Class II |