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 |
|---|---|---|---|---|---|
| K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | Respironics, Inc. | CBK | Class II | |
| K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons | Playtex Products, Inc. | HIL | Class II | |
| K072360 | K-Y Brand Intrigue Intense Warming Sensation | Mcneil-Ppc, Inc. | NUC | Class II | |
| K072314 | Disposable Powder Free Vinyl Synthetic Exam Gloves, with Aloe Vera, Green Color | Xuzhou Full Sun Medical Products Ltd. | LYZ | Class I | |
| K071928 | The Invacare Flyer, Model Ipc 100 | Invacare GmbH | CAW | Class II | |
| K071349 | Neurosign Laryngeal Electrodes | Magstim Inc. | ETN | Class II | |
| K071236 | Alcon Multi-Purpose Solution | Alcon, Inc. | LPN | Class II | |
| K071150 | Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire | Heinz Kurz GmbH Medizintechnik | ETD | Class II | |
| K071122 | Disposable Powdered Vinyl Exam Glove, Yellow Color | Xuzhou Full Sun Medical Products Ltd. | LYZ | Class I | |
| K073273 | Equal Dose 1.0 | Nucletron BV | IYE | Class II | |
| K073272 | Workstationone Breast Imaging Workstation | Three Palm Software | LLZ | Class II | |
| K072835 | Liquichek Microalbumin Control Level 1, Level 2, Control Minipak | Bio-Rad, Diagnostics Grp. | JJY | Class I | |
| K072766 | Pvmed Ddr 2520 Digital Imaging System | Portavision Medical, LLC | IXK | Class II | |
| K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant Mcc | Bio-Rad, Diagnostics Grp. | DIF | Class I | |
| K072637 | Divo | A2d Imaging, LLC | LLZ | Class II | |
| K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2 | STERIS Corporation | JOJ | Class II | |
| K071942 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | KWP | Class II | |
| K071562 | D3 Hematology Analyzer, Model D3 | Drew Scientific, Ltd. | GKZ | Class II | |
| K073083 | Vitek 2 Gram Negative Piperacillin | bioMerieux, Inc. | LON | Class II | |
| K073059 | Probeat with Discrete Spot Scanning System | Hitachi, Ltd., Power Systems Group | LHN | Class II | |
| K073033 | Legacy Dental Implants | Implant Direct, LLC | DZE | Class II | |
| K072890 | Stasilon Fr | Entegrion, Inc. | QSY | Unclassified | |
| K072883 | Ice-Sense | Arbel Medical, Ltd. | GEH | Class II | |
| K072785 | Twinfix Ft Pk | Smith & Nephew, Inc. | HWC | Class II | |
| K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | GXP | Class II | |
| K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | MUU | Class II | |
| K072473 | Chase Mr System | Chase Medical, Inc. | LNH | Class II | |
| K072267 | Total Hip Surgetics Navigation System | Praxim S.A | HAW | Class II | |
| K072226 | Impix Spacer | Medicrea Technologies | MAX | Class II | |
| K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | DXJ | Class II | |
| K073353 | Do-All Dental Handpiece Lubricant | Prodrive Systems, Inc. | EFB | Class I | |
| K073264 | D-Stat Dry Clear Hemostatic Bandage, Model 3005 | Vascular Solutions LLC | QSX | Unclassified | |
| K073226 | Cinch Knotless Fixation Implant System | C2m Medical, Inc. | MBI | Class II | |
| K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | CEM | Class II | |
| K073148 | Idrives, Idrivec, Idrivef with Vascular Indications | Power Medical Interventions, Inc. | GDW | Class II | |
| K073107 | Valencia Skin Applicator Set, Model: 189.701 | Nucletron BV | JAQ | Class II | |
| K073044 | Heartway Power Mobility Scooter, Model Pt7 | Heartway Medical Products Co., Ltd. | INI | Class II | |
| K073009 | Oneport Surgical Trocar System | ConMed Corporation | GCJ | Class II | |
| K072929 | Limitorr Volume Limiting External Csf Drainage and Monitoring System, Models Ins9020, Ins9030 | Integra LifeSciences Corporation | JXG | Class II | |
| K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5 | Biosite Incorporated | JJY | Class I | |
| K072840 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | NKB | Class II | |
| K072776 | The Crosser System | Flowcardia, Inc. | PDU | Class II | |
| K072690 | Hemaway Seat | Hemaway, LLC | LRL | Unclassified | |
| K072651 | Cryospray Ablation System, Model Cc2-Nam | CSA Medical | GEH | Class II | |
| K072550 | Sightsure Operational Indicator, Model Ss301 | Medevice, Inc. | KNT | Class II | |
| K072513 | Dm-EMG | Gvp Elettronica SRL | DWJ | Class II | |
| K072393 | Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01 | Phadia AB | LSW | Class II | |
| K072374 | Compass | Scanditronix Wellhofer GmbH | IYE | Class II | |
| K072354 | Guidewire, Model G-V220-3527S and Others | Accellent, Inc. | OCY | Class II | |
| K072137 | Avita Bluetooth Blood Pressure Monitor, Model: Bpm656zb | Avita Corporation | DXN | Class II |