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 |
|---|---|---|---|---|---|
| K043120 | Min-Filter/s, Uni-Filter Junior, Uni-Filter/s Angled and Uni-Filter | GE Healthcare | CAH | Class II | |
| K043003 | Tcm40 Monitoring System | Radiometer Medical ApS | LKD | Class II | |
| K041838 | Mps (or Mps-T) | Innerspace, Inc. | GWM | Class II | |
| K033646 | Trifit 700 | Healthfirst Corp. | DRT | Class II | |
| K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote S.p.A. | IYN | Class II | |
| K050307 | Airis Elite Rapid Body Coil | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K050298 | Ipacs Prism-5.0 | Realtimeimage, Inc. | LLZ | Class II | |
| K050253 | Usgi Shapelock Endoscopic Guide | Usgi Medical | FED | Class II | |
| K050200 | Magnetom Trio a Tim System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K050089 | Bd Phoenix Automated Microbiology System - Ampicillin-Sulbactam (Gp) 2-32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050075 | Vitek 2 Gram Positive Daptomycin | bioMerieux, Inc. | LON | Class II | |
| K043461 | Custodiol | Dr. Franz Kohler Chemie GmbH | KDL | Class II | |
| K043457 | Modification to Endovascular Guide Wire | Stereotaxis Inc | DQX | Class II | |
| K043425 | Sheathes Needle Guide, Model Ng-Sr-a-484-Kit (There Will Be Various Model Numbers Based on Transducer and Cover) | Sheathing Technologies Inc | ITX | Class II | |
| K043242 | Triage Tox Drug Screen | Biosite Incorporated | LDP | Class II | |
| K042272 | Acon Mononucleosis Rapid Test Strip (Whole Blood/serum/plasma) | Acon Laboratories, Inc. | KTN | Class II | |
| K041884 | Mueller Water Conditioning Water Purification System for Hemodialysis | Mueller Water Conditioning, Inc. | FIP | Class II | |
| K032410 | Snorenti | James P Boyd | LQZ | Class II | |
| K050347 | Modification to Cryocare Cs Surgical System | Varian Medical Systems, Inc. | GEH | Class II | |
| K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | LHI | Class II | |
| K050308 | Thermal Cautery Probe | Microline Surgical, Inc | HQR | Class II | |
| K050303 | 5 Sec Digital Clinical Thermometer, Models St8630x, St8640x, St8730x, St8740x, St8930x, St8940x, St8030x, St8040x. | Mesure Technology Co., Ltd. | FLL | Class II | |
| K050176 | Vortex Ez Vascular Access Port | Boston Scientific Corporation | LJT | Class II | |
| K050100 | Rna1c Hemoglobin A1c Control for Bayer Dca2000 and Dca2000+ Analyzer | Bionostics, Inc. | JJX | Class I | |
| K050041 | Synthes (USA) Sterile Sternal Fixation System | Synthes (USA) Products LLC | JDQ | Class II | |
| K050004 | Philips Heartstart Frx Defibrillator, Model 861304 | Philips North America LLC | MKJ | Class III | |
| K043599 | Moments Menopause Check, Model 9113 | Phamatech Inc. | CGJ | Class I | |
| K043507 | Acon Oxy II One Step Oxycodone Test Strip; Test Device | Acon Laboratories, Inc. | DJG | Class II | |
| K043284 | Endoassist | Armstrong Healthcare Limited | GCJ | Class II | |
| K043170 | Bosworth Bond | Harry J. Bosworth Co. | KLE | Class II | |
| K043010 | Holter Recorder H3+ | Mortara Instrument, Inc. | MWJ | Class II | |
| K042813 | Biobeam Narrow Band Light Therapy Devices | Life Without Pain, LLC | ILY | Class II | |
| K042110 | Beamcath | Beampoint AB | EZL | Class II | |
| K041908 | Contact Heat-Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | NTU | Class II | |
| K050317 | Burane Xl | Wavelight Laser Technologie AG | GEX | Class II | |
| K050313 | Bis Srs (Semi-Resuable Sensor) | Aspect Medical Systems, Inc. | GWY | Class I | |
| K050299 | Hrk-123 Knee Array Coil | Mri Devices Corp. | MOS | Class II | |
| K050223 | Vivawave Microwave Ablation System, Coaxial Introducer | Vivant Medical, Inc. | GEI | Class II | |
| K050196 | Sectra Ids5 Workstation | Sectra-Imtec AB | LLZ | Class II | |
| K043575 | Dermillume, Model Pro1000 | Care Electronics, Inc. | GEX | Class II | |
| K043410 | Epiphysis Screw | I.T.S. Implantat-Technologie-Systeme GmbH | HWC | Class II | |
| K043255 | Ellipse Light Spt | Danish Dermatologic Development A/S | GEX | Class II | |
| K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | EHD | Class II | |
| K041885 | Bioflex Ld-175 and Ld-1200 Treatment Heads | Meditech International Inc | ILY | Class II | |
| K050386 | Prime & Bond Nt Dual Cure Nano-Technology Universal Dental Adhesive System | Dentsply International, Inc. | KLE | Class II | |
| K050380 | Xario Diagnostic Ultrasound System, Model Ssa-660A | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K043602 | Quadrant Retractor System | Medtronic Sofamor Danek | GAD | Class I | |
| K043297 | Medicon 2.4 Mandibular Reconstruction Plating System | Medicon, E.G. | JEY | Class II | |
| K042563 | Durex Play Warmer Lubricant | Ssl Americas, Inc. | KMJ | Class I | |
| K042054 | Silimed Pectoral Implant | Silimed, LLC | MIB | Class II |