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 |
|---|---|---|---|---|---|
| K911271 | Adhesive Precoated Brackets | Unitek Corp. | DYH | Class II | |
| K911227 | New Sterility Character/sarns Oxygenator Products | 3M Health Care, Sarns | DTZ | Class II | |
| K911151 | Power Wheelchair - Tilt & Recline Seating System | Tarsys Engineering, Inc. | ITI | Class II | |
| K911089 | Stealth Catheter System | Target Therapeutics | LIT | Class II | |
| K911042 | Gammat Electroformed Gold Coping | Gramm Surface Technology, Inc. | EJT | Class II | |
| K911031 | The Tramond Pin | Sport Service, Inc. | JDR | Class II | |
| K911026 | Staple Blade for Tibial Osteo/staple Blade L'union | Sport Service, Inc. | JDR | Class II | |
| K911021 | Plate Blade with Cursor of L'union | Sport Service, Inc. | KTT | Class II | |
| K911020 | Ligamentoplastic Staple of L'union | Sport Service, Inc. | JDR | Class II | |
| K910987 | 7Fr. and 8Fr. Triguide Guiding Catheter Add. Curve | Scimed | DQO | Class II | |
| K910873 | Bd Angiographic Syringe W/a Rotating Tip | BD Becton Dickinson Vacutainer Systems Preanalytic | DXT | Class II | |
| K910627 | Alpha-Fil, Alpha-Base & Alpha-Silver, Modification | Foremost Mfg., Inc. | EBF | Class II | |
| K910596 | Dcw Modular Distal Femoral System | Dow Corning Wright | KRO | Class II | |
| K910339 | Avd Intimax Occlusion Catheter | Applied Vascular Devices, Inc. | DQT | Class II | |
| K905795 | Sgarlato Flexible Hinge Toe Implant | Sgarlato Laboratories, Inc. | KWH | Class II | |
| K905439 | Hypergel Protective Wound Gel | Scott Health Care | KMF | Class I | |
| K901454 | Vena Cava Filter | Vena-Tech, Inc. | DTK | Class II | |
| K912169 | Widex Model Qx in-the-Ear Hearing Aid | Widex Hearing Aid Co., Inc. | ESD | Class I | |
| K911953 | Medi Guard Sheets/underlays | Sancella, Inc. | KME | Class I | |
| K911952 | Medi Guard Underpad | Sancella, Inc. | KME | Class I | |
| K911948 | Medi Guard Pillowcase | Sancella, Inc. | KME | Class I | |
| K911582 | Stak-Chex | Streck Laboratories, Inc. | JCN | Class II | |
| K911401 | Abbott Lifecare 5000 Pump | Abbott Medical | FRN | Class II | |
| K911396 | Sr1 Estradiol Enzyme Immunoassay | Serono-Baker Diagnostics, Inc. | CHP | Class I | |
| K911329 | Bard(r) Surecatch Pediatric Urine Collect Device | C.R. Bard Inc | FOC | Class II | |
| K911106 | Model Baxter Ultrafiltrate Meter and Drain Bag | Baxter Healthcare Corporation | KOC | Class II | |
| K910955 | Hsv-1 Igm Elisa Test | Gull Laboratories, Inc. | LGC | Class II | |
| K910954 | Hsv-1 Igg Elisa Test | Gull Laboratories, Inc. | LGC | Class II | |
| K910953 | Hsv-2 Igm Elisa Test | Gull Laboratories, Inc. | LGC | Class II | |
| K910952 | Hsv-2 Igg Elisa Test | Gull Laboratories, Inc. | LGC | Class II | |
| K910912 | Moss Nasal Tube Mark IV | Moss Medical Products | KNT | Class II | |
| K910876 | Autocath(tm) Set | Cook Incorporated | GBM | Class II | |
| K910532 | Uram Ophthalmic Laser Endoscope | Martin S. Knopf Assoc., Inc. | HQF | Class II | |
| K910370 | Philips Integris V3000 and V4000 | Philips North America LLC | IZI | Class II | |
| K910188 | Flowplus Ac330 Pump Garments | Huntleigh Technology, Inc. | JOW | Class II | |
| K910040 | Ambu Sir 2 (Silicone Resuscitator), Adult | Ambu, Inc. | BTM | Class II | |
| K905539 | 3M 6830 Electrode | 3M Healthcare | GXY | Class II | |
| K905456 | L328 Transducer | Acuson Corp. | MAA | Class II | |
| K905310 | Miniox V Pulse Oximeter | Catalyst Research Corp. | DQA | Class II | |
| K905140 | Satlite Plus Pulse Oximeter | Datex Division Instrumentarium Corp. | DQA | Class II | |
| K905071 | Mx Cycler | Dakmed, Inc. | EKX | Class I | |
| K904920 | Ambu Matic Automatic Resuscitator | Ambu, Inc. | BTL | Class II | |
| K904165 | Sensory Nerve Conduction Velocity Testing Unit | Occupational Preventive Diagnostics, Inc. | JXE | Class II | |
| K901811 | Add'l Data E-Sp Multipurpose Epidural Spinalneedle | Neuro Technology | BSP | Class II | |
| K910837 | Sri Tsh Immunenzymetric Assay | Serono-Baker Diagnostics, Inc. | JLW | Class II | |
| K910805 | Nd:yag Laser Systems (Various Models) | Heraeus Lasersonics, Inc. | HQF | Class II | |
| K911954 | Remedi(tm) Drug Profiling System, Modification | Bio-Rad | DJR | Class II | |
| K911466 | Innofluor Valproic Acid Calibrator Set | Intl. Bioclinical, Inc. | DLJ | Class II | |
| K911438 | Turbo Accelerator W/clin Diag Software Cartridge | Bio-Tek Instruments, Inc. | JJQ | Class I | |
| K911212 | Lm-150Ht Light Source | Leisegang Medical, Inc. | ESI | Class III |