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 |
|---|---|---|---|---|---|
| K011622 | Osteo Ic Femoral and Tibial Nails and Osteo Retrograde/antegrade Femoral Nails with T2 Locking Screws | Howmedica Osteonics Corp | HSB | Class II | |
| K011572 | Quantitative Gated Spect (Qgs), Quantitative Perfusion Spect (Qps) | Digirad Corp. | KPS | Class II | |
| K011534 | EEG Mis Monitor Model # a-2000; Bis Engine | Aspect Medical Systems, Inc. | OLW | Class II | |
| K011506 | Omnilink .035 Biliary Stent System | Boston Scientific Corporation | FGE | Class II | |
| K011367 | Excel Fracture Cemented Hip Stem | Depuy Orthopaedics Inc. | JDI | Class II | |
| K011262 | Modification to the Bold Screw | New Deal, S.A. | HWC | Class II | |
| K011183 | Omniport Hand and Instrument Access Device | Advanced Surgical Concepts (Asc) | GCJ | Class II | |
| K011040 | Cryocare Cardiac Surgical System | Varian Medical Systems, Inc. | OCL | Class II | |
| K010919 | Male Natural Rubber Latex Condom | Innolatex Sdn. Bhd | HIS | Class II | |
| K010837 | Handmaster | Neuromusclar Electrical Stimulation Systems, Ltd. | GZI | Class II | |
| K010817 | Mx8000 V5.0 CT System | Philips North America LLC | JAK | Class II | |
| K010815 | Ntero Nomad System | Ntero Surgical, Inc. | GEI | Class II | |
| K003920 | Cordis M3 Pta Dilatation Catheter | Cordis US Corp. | DQY | Class II | |
| K003905 | Acti-Icp Monitoring System | Innerspace, Inc. | GWM | Class II | |
| K003433 | Neuro-Train III (3) | Sterne Equipment Co., Ltd. | IPF | Class II | |
| K011526 | Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 | Medtronic, Inc. | MJN | Class II | |
| K011523 | Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Bpw138 | Rossmax International Ltd. | DXN | Class II | |
| K011446 | Barrierplus Powder-Free Synthetic Polyisoprene Surgical Gloves | Barriermed, Inc. | KGO | Class I | |
| K011409 | Slt Laserpro Cth Holmium Laser System | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K011200 | Gilb, Model 8010 | 3M Company | EMA | Class II | |
| K011156 | Bci 3403 Sleep Screening Pulse Oximeter | Bci, Inc. | DQA | Class II | |
| K011035 | Dimension Drug Calibrator, Model Dc22b | Siemens Healthcare Diagnostics Inc. | JIX | Class II | |
| K010207 | Portable Instensive Care Unit | Medical Research Laboratories, Inc. | MKJ | Class III | |
| K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474 | Drager Medizintechnik GmbH | CBK | Class II | |
| K010055 | Cook Vascular Electrosurgical Dissection Sheath | Cook Vandergrift, Inc. | DRE | Class II | |
| K010049 | Pulseco Hemodynamic Monitor Cm71 | Lidco Ltd | DXG | Class II | |
| K002543 | Comoact Ultrasonic Nebulizer, Model 3060 | San UP S.A. | CAF | Class II | |
| K011795 | Worland Unicondylar Tibial Bearing | Zimmer GmbH | HRY | Class II | |
| K011693 | Trumpf Surgical Lights, Models 301,501,701,1001 | Hill-Rom Inc. | FSY | Class II | |
| K011598 | Water for Assisted Reproductive Technologies (A.r.t.) Use | FUJIFILM Biosciences Inc. | MTW | Class II | |
| K011585 | Fast Thermometer Models St713c and St713f | Mesure Technology Co., Ltd. | FLL | Class II | |
| K011509 | Barrett Unicondylar Tibial Bearing | Zimmer GmbH | HRY | Class II | |
| K011464 | Rx Viatrac 14 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation Catheter, Rx Herculink 14 Biliary Stn | Vascular Intervention | DQY | Class II | |
| K011463 | Vitros Immunodiagnostic Products Folate Range Verifiers | Ortho-Clinical Diagnostics, Inc. | JJX | Class I | |
| K011462 | Oil for Tissue Culture | Conception Technologies | MQL | Class II | |
| K011450 | Silicone Impression Material | Northeast Resins & Silicones, LLC | ELW | Class II | |
| K011411 | Self-Adhesive Electrodes | Pain Management Technologies | GXY | Class II | |
| K011384 | Hardydisk Novobiocin, 30Mcg, Model Z883 | Hardy Diagnostics | JTN | Class II | |
| K011316 | Biocurve Soft (Hioxifilcom a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear and Blue Visibility-Handling T | American Contact Lens, Inc. | LPL | Class II | |
| K011250 | Vitros Immunodiagnostic Products Hbsag Controls | Ortho-Clinical Diagnostics, Inc. | JJX | Class I | |
| K011234 | Biocurve Soft (Hioxifilcon B) Spherical and Toric Soft Contact Lens for Daily Wear (Clear and Blue Visibility-Handling L | American Biocurve, Inc. | LPL | Class II | |
| K011231 | Chlorinated Powdered Latex Examination Gloves, Blue, Green | Protection Gloves Sdn. Bhd. | LYY | Class I | |
| K011148 | Ultraconcentrator System | Interpore Cross Intl. | FJI | Class II | |
| K011134 | Oxygen Supply Tubing, Model 1115 | Hudson Respiratory Care, Inc. | BYX | Class I | |
| K011125 | Nasal Cannula, with and without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci | Hudson Respiratory Care, Inc. | CAT | Class I | |
| K011113 | Hydragel ISO-Pal K20 (Pn 3022); Hydragel 7 ISO-Pal (Pn 4112); Hydragel 15 ISO-Pal (Pn 4132) | Sebia | CIN | Class II | |
| K011103 | Bd Spring Based Syringe | BD | MEG | Class II | |
| K011095 | Model I0-3Duims 3D Ultrasound Management System | Iodp SA | IYO | Class II | |
| K011026 | Fortaderm Wound Dressing | Organogenesis, Inc. | KGN | Unclassified | |
| K010986 | Lunapads | Lunapads International Products, Ltd. | NUQ | Class I |