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 |
|---|---|---|---|---|---|
| K091251 | Cerner Fetalink (Version 1.0) | Cerner Corporation | HGM | Class II | |
| K091144 | Synthes Matrixmandible Preformed Reconstruction Plates | Synthes (USA) Products LLC | JEY | Class II | |
| K090936 | Single-Channel Handheld Electrocardiograph, Model Ecg80a | Contec Medical System Co., Ltd. | DPS | Class II | |
| K090258 | Venturi Npwt V. II Advanced Vacuum System | Talley Medical | OMP | Class II | |
| K083208 | Saturn Active Laser System | Research Instruments Ltd | MRX | Class II | |
| K092291 | Skintact and Various Other Tradenames | Leonhard Lang GmbH | DRX | Class II | |
| K092217 | Mercury Vco2 | Respironics Novametrix, LLC. | BZK | Class II | |
| K092140 | Ge Vivid I Diagnostic Ultrasound, Ge Vivid Q Diagnostic Ultrasound | GE Medical Systems Israel, Ultrasound, Ltd. | IYO | Class II | |
| K091902 | 1.5T 8-Channel Small Extremity Coil, Model 800494, 3.0T 8-Channel Small Extremity Coil, Model 800484 | Invivo Corporation | MOS | Class II | |
| K091628 | Optimax, Compact 2, Optimax 2010, Ecomax | Protec GmbH & Co. KG | IXW | Class II | |
| K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | HIH | Class II | |
| K091452 | Fore-Sight, Model Mc-2000 Series (Mc 2000, Mc2010, Mc-2020,Mc2030) | Cas Medical Systems, Inc. | MUD | Class II | |
| K091430 | Care Pal, Model Cpw-10X | Digio2 International Co., Ltd. | DRG | Class II | |
| K091412 | Clean Peak Flow Meter | Viasys Healthcare GmbH | BZH | Class II | |
| K091306 | Amsure PVC Intermittent Catheter | Amsino International, Inc. | EZD | Class II | |
| K091200 | Xtract Syringe Keys | Xtract Solutions | FMF | Class II | |
| K090581 | Tantalum Bead Set, Model P003175 | Halifax Biomedical Inc. | NEU | Class II | |
| K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | OCC | Class II | |
| K092222 | Thermapulse | Palomar Medical Products, Inc. | ILY | Class II | |
| K092201 | Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial Base | Wrightmedicaltechnologyinc | JWH | Class II | |
| K092053 | Maxima-M Straight Attachment, Maxima-M Contra Angle Sheath | Handpiece Headquarters | EGS | Class I | |
| K091682 | Lsvt C or Lsvt Companion, Model V.1 | Lsvt Global, LLC | LEZ | Unclassified | |
| K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, | Hollister, Inc. | GBM | Class II | |
| K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer USA Co. Ltd. | FLE | Class II | |
| K090710 | Mercury CPAP | Mercury Medical | BYE | Class II | |
| K083747 | Terumo Pall Al3x Arterial Filter | Terumo Cardiovascular Systems Corporation | DTM | Class II | |
| K083448 | Cable, Transducer, Model 2400Gn | ConMed Corporation | DQA | Class II | |
| K082977 | Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup | Mk Bio, Inc. | LDJ | Class II | |
| K092323 | Contura Cavity Maintenance Catheter | Senorx, Inc. | JAQ | Class II | |
| K092232 | Modification To:vashe Wound Cleansing System, Model 9000-0014 | Puricore, Inc. | FRO | Unclassified | |
| K091497 | K-Laser K-1200, Model 12 W | Eltech S.R.L | ILY | Class II | |
| K091320 | Spectra Sp II, Spectra Denta II | Lutronic Corporation | GEX | Class II | |
| K082699 | Elecsys Troponin I and Troponin I Stat Test Systems | Roche Diagnostics GmbH | MMI | Class II | |
| K091827 | S. Aureus Pna Fish | Advandx, Inc. | NXX | Class I | |
| K091739 | Semi Automatic Electronic Blood Pressure Monitor, Models Kd-3917, Kd 3909 | Andon Health Co., Ltd | DXN | Class II | |
| K091738 | Semi Automatic Electronic Blood Pressure Monitor, Model Kd-388Bd | Andon Health Co., Ltd | DXN | Class II | |
| K091737 | Fully Automatic Electronic Blood Pressure Monitor, Models: Kd-5917, Kd-5915, Kd-5031 | Andon Health Co., Ltd | DXN | Class II | |
| K091481 | Easyplus Mini R13n Self Monitoring Blood Glucose System | Eps Bio Technology Corp. | NBW | Class II | |
| K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | DRS | Class II | |
| K091186 | Kodak 1500 Intraoral Camera | Eastman Kodak Company | EIA | Class I | |
| K090818 | Karl Storz -Endoscope Sterilization Trays, Models 39402As, 39301Hcts, 39301Bs | Karl Storz Endoscopy-America, Inc. | KCT | Class II | |
| K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | NBL | Class II | |
| K083250 | Neuromed Electroanalgesic Delivery Systems | Aa Neuromed Corp. | GZJ | Class II | |
| K083031 | Portex Uniperc Percutaneous Dilation Tracheostomy Kit | Abbott Medical | BTO | Class II | |
| K092022 | Tissu Trans Harvest Tubing | Summit Medical, LLC | KYZ | Class I | |
| K091976 | Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail | Biomet Trauma | HSB | Class II | |
| K091533 | Slicks Sectional Matrix and Matrix Bands, Models Sm100, Sm150, Sm175, Sm200, Sm300, Smh100, Smh150, Smh175 and Smh200 | Garrison Dental Solutions | JEP | Class I | |
| K091134 | Custom Spine Regent Anterior Cervical Plate | Custom Spine, Inc. | KWQ | Class II | |
| K091074 | Aem Disposable Electrodes,model Eso300 Series | Encision, Inc. | GEI | Class II | |
| K081360 | Pathfast Ck-Mb-II, Pathfast Myo-II | Mitsubishi Kagaku Iatron | JHX | Class II |