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 |
|---|---|---|---|---|---|
| K041066 | Encore Reverse Shoulder Prosthesis | Encore Medical, LP | PHX | Class II | |
| K050591 | Modification to Raven Bacterial Spore Strips | Raven Biological Laboratories, Inc. | FRC | Class II | |
| K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems, Inc. | IYE | Class II | |
| K050235 | Iq 200 Urine Analyzer Body Fluids Module | Iris International, Inc. | GKL | Class II | |
| K043393 | Reprocessed Ep Technologies Electrophysiology Catheters | Alliance Medical Corp. | NLH | Class II | |
| K043344 | Dialysis Services Water Treatment & Distribution System | Dialysis Services, Inc. | FIP | Class II | |
| K042715 | Titan Dental Implant Attachment | Titan Implants, Inc. | NHA | Class II | |
| K042672 | 14F Dual Floating Dialysis Catheter/tray | Cardio Med Supplies, Inc. | MSD | Class II | |
| K042058 | Oneflow Fvc, Oneflow Fvc (Kit), Oneflow Fvc Screen | Clement Clarke Intl., Ltd. | BZG | Class II | |
| K042040 | Triactiv System | DSM Biomedical, Inc. | NFA | Class II | |
| K050630 | Pivot Steerable Microcatheter | Boston Scientific - Precision Vascular | KRA | Class II | |
| K050627 | Lifestent Turbo Biliary Stent Systems | Edwards Lifesciences LLC | FGE | Class II | |
| K050584 | Gs-128 Gradient Compression System | Medmark Technologies, LLC | JOW | Class II | |
| K050551 | Voyager Personal Imaging Device | Ardent Sound, Inc. | IYO | Class II | |
| K050400 | Bd Phoenix Automated Microbiology System - Cephalothin (Gp) 0.5-64 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050139 | Modification to: Export Catheter | Medtronic, Inc. | QEZ | Class II | |
| K050074 | 12-Lead Resting Electrocardiograph, Models Cp100 & Cp200 | Welch Allyn Inc | DPS | Class II | |
| K050037 | Triage Tox Drug Screen Controls | Biosite Incorporated | DIF | Class I | |
| K043361 | Accuheart Electrode Belt | Advanced Bioelectric Corporation | DRX | Class II | |
| K043315 | Vanguard Reprocessed Hand-Activated Ultrasonic Scalpel | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K043225 | Vanguard Reprocessed Ultrasonic Scalpel | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K043033 | Global Treasures Fluid Filled Teether | Global Treasure Industries, Ltd. | KKO | Class II | |
| K050634 | Modification to: Arthrex V-Tak | Arthrex GmbH | HWC | Class II | |
| K050512 | Stryker Locked Plating System | Howmedica Osteonics Corp | HRS | Class II | |
| K050354 | Perioscan Ultrasonic Scaler | Sirona Dental Systems GmbH | ELC | Class II | |
| K050138 | Modification to: Restoration Modular System | Howmedica Osteonics Corp | JDI | Class II | |
| K043497 | Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-Ov, as-1,As-1-0,As-1-V, as-1-Ov | J. Morita USA, Inc. | EFB | Class I | |
| K043488 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K042999 | Carto Xp Ep Navigation System, Software Verison 8 | Biosense Webster Inc | DQK | Class II | |
| K042482 | Bass Antalgic-Trak | Traction Masters, LLC | ITH | Class II | |
| K042418 | Kd-575 Memory Automatic Electronic Blood Pressure Monitor | Kodon(Tianjin)Electronic&Electrical Apparatus Co. | DXN | Class II | |
| K050585 | Microscan Dried Gram Negative Mic/combo Panels Amoxicillin/k. Clavulanate | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K050531 | Powdered Nitrile Examination Gloves (Blue,white) | Spi Gloves Sdn. Bhd. | LZA | Class I | |
| K050527 | Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractabl | Spi Gloves Sdn. Bhd. | LYY | Class I | |
| K050426 | Temposil, Model 6720 | Coltene /Whaledent AG | EMA | Class II | |
| K050422 | 550 Txt Treatment Table | Siemens Medical Solutions USA, Inc. | JAI | Class II | |
| K050293 | Fotona Xp Plus Nd: Yag Family of Laser Systems, Fontona Dualis Xp Plus Nd: Yag Family of Laser Systems | Fotona D.D. | GEX | Class II | |
| K050237 | Starshield V3 RF Trnt | Medtronic Navigation, Inc | LNH | Class II | |
| K050201 | Aeu-14Cf Expendition | Aseptico, Inc. | EIA | Class I | |
| K050137 | Temptouch Dermal Thermometer | Xilas Medical, Inc. | FLL | Class II | |
| K050125 | Rap/tac/csa Control - Level 1,2,3,4 | More Diagnostics Inc. | JJY | Class I | |
| K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions LLC | GEX | Class II | |
| K043571 | Cryocheck Clot S | Precision BioLogic Inc. | GGP | Class II | |
| K043329 | Omnilux Revive and Blue | Photo Therapeutics Limited | GEX | Class II | |
| K042972 | Xp Technology Ultrasonic Scaler | American Eagle Instruments | ELC | Class II | |
| K042887 | Accu-Chek Spirit | Disetronic Medical Systems | LZG | Class II | |
| K042727 | Pocket Size Resuscitator/model: M16201r and M16201a | Foremount Ent. Co., Ltd. | CBP | Class II | |
| K042523 | Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories | Richard Wolf Medical Instruments Corp. | FJL | Class II | |
| K042208 | Isis Mer System/elekta Mer System | Inomed Medizintechnik GmbH | GZL | Class II | |
| K041311 | Tiger Endotracheal Tubes (Various Models and Sizes) | Tiger Medical Products, Ltd. | BTR | Class II |