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 |
|---|---|---|---|---|---|
| K020854 | Modification to Fox Pta Catheter | Jomed AG | LIT | Class II | |
| K020841 | Avon Patellar Component | Howmedica Osteonics Corp | KRR | Class II | |
| K020206 | Intraoral Camera Me-15 | Dent Corp. Research & Development | EIA | Class I | |
| K020099 | Mega Beam/ceralas Nonsterile Collimating Handpiece | Biolitec, Inc. | GEX | Class II | |
| K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | MSD | Class II | |
| K012956 | Hygia Health Services Reprocessed Nu Tech Combo, Model Left Limb and Right Limb | Hygia Health Services, Inc. | JOW | Class II | |
| K011541 | Zoll Pad with CPR Aid | ZOLL Medical Corporation | MKJ | Class III | |
| K011068 | Rhigene Ndna Test System for Imagetiter, Model Cl100l | Rhigene, Inc. | KTL | Class II | |
| K002578 | Axillary Access Arterial Cannula | Edwards Lifesciences LLC | DWF | Class II | |
| K020990 | Simplicity Soft Qd II Infusion Set for Infusion And/or Injection of Fluids into the Body Below the Surface of the Skin | Sterling Medivations, Inc. | FPA | Class II | |
| K020912 | Simplicity Easy Soft Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K020396 | Biocellect -Perio | Imtec Corp. | LYC | Class II | |
| K020363 | Great Glove Latex Examination Powderfree Gloves with Protein Labelling Claims (50 Micrograms or Less) | Great Glove Sdn Bhd | LYY | Class I | |
| K020343 | Surgassist System; Wireless Remote Control (Component); Wired Remote Control | Power Medical Interventions, Inc. | GDW | Class II | |
| K020151 | Ud-1000 Ultrasonic A/b Scanner | Tomey Corp. USA | IYO | Class II | |
| K020106 | Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger | Gish Biomedical, Inc. | DTR | Class II | |
| K020089 | Mahurkar Triple Lumen Catheter, 12 Fr | Kendall | NIE | Class II | |
| K011524 | Immediate Stabilizing Device (Isd) | O Co., Inc. | DZE | Class II | |
| K021052 | Model Gt010706 Electronic Thermometer | Global Treasure Industries, Ltd. | FLL | Class II | |
| K020832 | Arthrocare Controller, Arthrocare Cable, Foot Control, Power Cord, Wands | ArthroCare Corporation | GEI | Class II | |
| K020654 | Stratasis Sling Kit | Cook Biotech, Inc. | PAG | Class II | |
| K020376 | Ahl Generic Glass Ionomer Aesthetic Restorative | Advanced Healthcare Ltd. | EMA | Class II | |
| K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Alcon Laboratories | LPL | Class II | |
| K020072 | Athos Laser | Quantel Medical | GEX | Class II | |
| K014025 | Hommed Sentry III Patient Monitor System with Card Reader | Hommed, LLC | DQA | Class II | |
| K013349 | Astronomer Plus System | Ep Technologies, Inc. | DQK | Class II | |
| K013067 | Frialoc Dental Implant System | Friadent GmbH | DZE | Class II | |
| K012758 | Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models Mr-9, Mr-9L, | Circon Video | FGB | Class II | |
| K012325 | Cardiovention Corx System, Model Fg 0001 | Cardiovention, Inc. | KFM | Class II | |
| K010281 | Merox Bipolar High Impedance Lead Models: Mex 53/13-Bp; 60/15-Bp; 45-Jbp; 53-Jbp | BIOTRONIK AG | DTB | Class III | |
| K021028 | Model Gt980201 Electronic Thermometer | Global Treasure, Ltd. | FLL | Class II | |
| K020454 | Chemistry Calibrator | JAS Diagnostics/Drew Scientific | JIT | Class II | |
| K020327 | Surgic IV Implant Control Unit | Nakanishi Inc. | EBW | Class I | |
| K020176 | Hdr Miami Applicator | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K013848 | U-Systems Diagnostic Ultrasound System U-2000 | U-Systems, Inc. | IYN | Class II | |
| K013672 | Bruges Distraction - Anchoring - Osteosynthesis System | Azary Technologies, LLC | JEY | Class II | |
| K012803 | Al-2000 Combined Biometer and Pachymeter | Tomey Corp. | IYO | Class II | |
| K012417 | Hygia Health Service Reprocessed Kendall Scd Sleeve, Models # 5329, 5330, 5345, 5480 | Hygia Health Services, Inc. | JOW | Class II | |
| K012226 | Monitoring System,model Argus Pb-1000 | Schiller, AG | MHX | Class II | |
| K020825 | King of Hearts Express + Af Monitor | Card Guard Scientific Survival, Ltd. | DSH | Class II | |
| K020766 | Hl168f | Health & Life Corporation | DXN | Class II | |
| K020765 | Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210 | Boston Scientific Corporation | KTI | Class II | |
| K020728 | Miethke Shunt System | Aesculap Inc | HCA | Class II | |
| K020649 | Envision Anterior Cervical Plate System | Ortho Development Corp. | KWQ | Class II | |
| K020548 | Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300 | Monobind, Inc. | CEC | Class II | |
| K020252 | Smartjet Grafting Liquid Applicator, Models Sk/s & Lk/2 | Terumo BCT, Ltd | FMF | Class II | |
| K020213 | Netlink/netscan | Rozinn Electronics, Inc. | DXH | Class II | |
| K020071 | Viridis Derma Laser | Quantel Medical | GEX | Class II | |
| K020047 | Rubicor Breast Biopsy Device | Rubicor Medical, Inc. | GEI | Class II | |
| K013253 | Hisonic-Trd Tinnitus Relief Device | Hearing Innovations, Inc. | KLW | Class II |