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 |
|---|---|---|---|---|---|
| K071552 | Puracol Plus Ag Collagen Microscaffold Wound Dressing | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K070109 | Neurometrix Advance | Neurometrix, Inc. | JXE | Class II | |
| K080883 | Cr-1 | Canon, Inc. | HKI | Class II | |
| K080865 | Fast1 Intraosseous Infusion System | Pyng Medical Corp. | FMI | Class II | |
| K080838 | Alveolus Alimaxx-E Esophageal Stent System | Alveolus, Inc. | ESW | Class II | |
| K080627 | Promedical Surgical Gowns, Models: 1002494A, 100770A | Promedical Products Co., Ltd. | FYA | Class II | |
| K080235 | Safety Infusion Set | Greiner Bio-One Vacuette North America | FMI | Class II | |
| K080005 | Sparmax Aspirator, Models Tc-2000V Nd Vc-701 | Ding Hwa Co., Ltd. | JCX | Class II | |
| K073640 | Architect Homocysteine Reagents, Calibrators and Controls | Axis-Shield Diagnostics, Ltd. | LPS | Class II | |
| K073447 | Surgi Gloves | Metacure Surgical Gloves Sdn Bhd | KGO | Class I | |
| K073440 | Foundation Cage | Corelink, LLC | MAX | Class II | |
| K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K072923 | Zoll E Series Defibrillator | ZOLL Medical Corporation | MKJ | Class III | |
| K072799 | Target Sterile Electrode | Vision Quest Industries, Inc. | GXY | Class II | |
| K072722 | Meddorna Wireless Prn Spirometer 100 | Meddorna, LLC | BZG | Class II | |
| K072206 | Erchonia Eml Laser | Erchonia Medical, Inc. | NHN | Class II | |
| K080985 | Quill Self-Retaining System (Srs) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | NEW | Class II | |
| K080943 | Synthes 4.5 Mm and 6.5 Mm Headless Compression Screws | Synthes (USA) Products LLC | HWC | Class II | |
| K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of Size #2-0 | DePuy Mitek, Inc. | NEW | Class II | |
| K080815 | Tosca II Anterior Cervical Plate System | Signus Medizintechnik GmbH | KWQ | Class II | |
| K080670 | Modification to Sphygmocor Cardiovascular Management System | ATCOR MEDICAL Pty Ltd | DSK | Class II | |
| K080524 | Centurion Sorbaview OTC | Centurion Medical Products, LP | NAD | Class I | |
| K080472 | Sedat Myshell Lite | Sedat | DTL | Class II | |
| K080425 | Cs Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 | Biosense Webster Inc | DRF | Class II | |
| K080358 | Plla, Ha Screw | Smith & Nephew, Inc. | HWC | Class II | |
| K080335 | Tornier Cinch Knotless Fixation Implant System | TORNIER Inc. | MBI | Class II | |
| K080315 | Derma Sciences Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | FRO | Unclassified | |
| K080274 | Ambulo 2400 | Tiba Medical, Inc. | DXN | Class II | |
| K080248 | Spectra Vrmiii Q-Switched Nd: Yag Laser System and Dye Handpieces | Lutronic Corporation | GEX | Class II | |
| K080232 | Zoll E Series 12Sl, Analysis Option | ZOLL Medical Corporation | MKJ | Class III | |
| K080174 | Phlebotomy Bag with Valve & 17G X 1, Model Cm-Ph17x1b, Cm-Ph17x1c | Cardio Med Supplies, Inc. | LHI | Class II | |
| K073715 | Elipo | Syneron Medical, Ltd. | GEX | Class II | |
| K073610 | Elta Advanced Wound Wash | Swiss American Products, Inc. | FRO | Unclassified | |
| K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel | Anacapa Technologies, Inc. | FRO | Unclassified | |
| K080821 | Microcuff Pediatric Endotracheal Tube | Kimberly-Clark Corporation | BTR | Class II | |
| K080686 | Westcon Horizon 49% (Hioxifilcon B) | Westcon Contact Lens Co., Inc. | LPL | Class II | |
| K080351 | Dexela Dex Top Mammography Workstation, Model Mamwkvi | Dexela, Ltd. | LLZ | Class II | |
| K080162 | Uno - One Piece Screw-Type Dental Implant | MIS Implants Technologies Ltd. | DZE | Class II | |
| K073187 | Peripheral Nerve Block Support Tray | Life-Tech, Inc. | CAZ | Class II | |
| K073166 | Endowave Infusion System | Ekos Corp. | KRA | Class II | |
| K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | LLZ | Class II | |
| K072061 | Masterscreen Pft, Masterscreen Pft CT, Masterscreen Pft Body | Viasys Healthcare GmbH | JEH | Class II | |
| K080836 | Modification to Endofast Reliant System | Endogun Medical Systems | FTL | Class II | |
| K080511 | Plexur-P | Osteotech Inc | MQV | Class II | |
| K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant | Ceremed, Inc. | KKY | Class II | |
| K080501 | Surechek Edge Blood Glucose Monitoring System, Model Sms-4240 | Taidoc Technology Corporation | NBW | Class II | |
| K080361 | Regenerex Tibial Components | Zimmer GmbH | MBH | Class II | |
| K080338 | Cuttersil Activator Universal Plus | Kulzer GmbH | ELW | Class II | |
| K080084 | Cell Gen Laser, Model Cg-4000 | Cell Gen Therapeutics, LLC | ILY | Class II | |
| K072811 | Marionette Sa, Model 001 001 & 001 002 | Kinetic Surgical, LLC | GCJ | Class II |