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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K132542 | Transgate Guide Catheter | Stryker Corp. | DQY | Class II | |
| K132507 | Vitek 2 Ast St Meropenem | bioMerieux, Inc. | LON | Class II | |
| K132376 | Discovery Mr750 3.0T, Discovery Mr450 1.5T, Discovery Mr750w 3.0T, Optima Mr450w 1.5T | GE Healthcare (GE Medical Systems, LLC) | LNH | Class II | |
| K131921 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | NUH | Class II | |
| K131850 | Tensyn Band | Dallen Medical, Inc. | HTN | Class II | |
| K131672 | Microcyn Scar Management Hydrogel | Sonoma Pharmaceuticals, Inc. | PFP | Class I | |
| K130997 | Neoveil | Gunze Limited | OXC | Class II | |
| K130689 | Symphony RF Generator | Thermigen, Inc. | GEI | Class II | |
| K130569 | Nd Nabil Dib Infusion Catheter | Translational Research Institute | KRA | Class II | |
| K130368 | Autolith Touch; Uro Touch | Northgate Technologies Inc. | FFK | Class II | |
| K130322 | Spm-300 | Bionet Co., Ltd. | BZG | Class II | |
| K133208 | Interlock-35 Fibered Idc Occlusion System | Boston Scientific Corporation | KRD | Class II | |
| K132614 | Peregrine Curved Illuminating Laser Probe | Peregrine Surgical, LLC. | HQB | Class II | |
| K132605 | Dosimetry Check Version 4 Release 1 | Math Resolutions, LLC | IYE | Class II | |
| K132527 | Digital Color Doppler Ultasound System | Sonoscape Company Limited | IYN | Class II | |
| K131778 | Fusion Vascular Graft and Fusion Bioline Vascular Graft | Maquet Cardiovascular LLC | DSY | Class II | |
| K131753 | Meridian | Ab Ardent | EBF | Class II | |
| K131284 | Gsp Neonatal Biotinidase Kit | Wallac Oy | NAK | Class II | |
| K131262 | Digital Electrocardiographs | Sonoscape Company Limited | DPS | Class II | |
| K131165 | Anker Dental Implant System | Alliance Global | DZE | Class II | |
| K131026 | Bosch Blood Pressure Meter (Bp5000 Bt) | Robert Bosch Healthcare Systems, Inc. | DXN | Class II | |
| K130829 | Iq Implants; Iq Implants; Iq Implants Abutments | IQ Implants Ltd | DZE | Class II | |
| K133138 | BD Veritor™ System Flu A+B Assay | Becton Dickinson & Co | PSZ | Class II | |
| K132552 | U&u Sterile Hypodermic Needle | U&u Medical Technology Co., Ltd | FMI | Class II | |
| K131904 | Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System with Heat Sa | AmeriWater LLC. | FIP | Class II | |
| K131128 | Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites | Omega Laboratories, Inc. | DIO | Class II | |
| K130853 | Idys(tm) C | Clariance, Inc. | ODP | Class II | |
| K122490 | Kulavac | CG Bio Co., Ltd. | OMP | Class II | |
| K122252 | Space Chamber Plus Compact Space Chamber Plus | Medical Developments International | NVP | Class II | |
| K133265 | Quadrox-Ir Adult and Small Adult | MAQUET CARDIOPULMONARY GmbH | KFM | Class II | |
| K133226 | Biograph Mmr | Siemens Medical Solutions USA, Inc. | OUO | Class II | |
| K132294 | Galaxy and Galaxy+plus Digital Radiography Systems | Radiology Solutions, LLC | KPR | Class II | |
| K132276 | Sterile Empty Glass Container, 250Ml, Sterile Empty Glass Container, 500 Ml, Sterile Empty Glass Container, 1000 Ml | Abbott Medical | KPE | Class II | |
| K132106 | Infinix Angio Workstation W/dts Software | Toshiba America Medical Systems, In.C | JAA | Class II | |
| K132102 | Bece Cad Zirkon Ht+ | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & Co | EIH | Class II | |
| K132085 | One Step Hcg Test Strip, One Step Hcg Test Cassette, One Step Hcg Test Midstream | Co-Innovation Biotech Co.,Ltd. | LCX | Class II | |
| K131243 | Non-Contact Infrared Thermometer | Shenzhen Jumper Medical Equipment Co.,Ltd. | FLL | Class II | |
| K130848 | Shanghai Phoenix Mechanical Wheelchair | Shanghai Phoenix Medical Equipment Co., Ltd. | IOR | Class I | |
| K130066 | Spectrum Spine Spinous Process Device | Spectrum Spine IP Holdings, LLC | PEK | Class II | |
| K122410 | I Rune (I-200L) | Medirune Co, Ltd. | NUH | Class II | |
| K131533 | Cayman Mi Plate System | K2M, Inc | KWQ | Class II | |
| K130759 | Humelock II Cementless Shoulder System | Fx Shoulder Solutions SAS | HSD | Class II | |
| K132913 | Voluson E6 / E8 / E8expert / E8expert Limited Edition / E10 | GE Healthcare | IYN | Class II | |
| K132574 | Pass Lp Spinal System | Medicrea International | OSH | Class II | |
| K132545 | Medivalve Acwire | Medivalve, Ltd. | DQX | Class II | |
| K132515 | Liaison N-Tact Pth Gen II, Control Set, Calibration Verifiers | Diasorin Inc. | CEW | Class II | |
| K131932 | Apnealink Pro | Resmed Germany, Inc. | MNR | Class II | |
| K131767 | Orthosensor Knee Balancer, Verasense Knee System | Orthosensor, Inc. | ONN | Class II | |
| K131275 | Microscan Dried Gram-Postive Mic/combo Panels | Siemens Helathcare Diagnostics, Inc. | LTT | Class II | |
| K130387 | Orthoalign Plus System | OrthAlign, Inc. | OLO | Class II |