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 |
|---|---|---|---|---|---|
| K080884 | Qhrv 1 - Health Assessment System | Medtechs, LLC | DPS | Class II | |
| K080882 | Cerec Opti Spray | Sirona Dental Systems GmbH | ELW | Class II | |
| K080768 | Ultratemp Firm, Fast and Regular Set | Ultradent Products Inc. | EMA | Class II | |
| K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | JAK | Class II | |
| K080261 | Impulse Iq Adjusting Instrument | Neuromechanical Innovations, LLC | LXM | Unclassified | |
| K080246 | Composite Aligner Button | Dentsply Interntional | NXC | Class II | |
| K080126 | Dio Protem Implant System | Dio Department Dsi, Inc. | DZE | Class II | |
| K080095 | Coramate/spirotome System | Medinvents | KNW | Class II | |
| K073716 | Life+cel or Lifecel Battery | Amco International Manufacturing & Design, Inc. | MKJ | Class III | |
| K073710 | Intouch Remote Presence Robotic System, Model Rp-7 | Intouch Technologies | DRG | Class II | |
| K073520 | Angiotech Cvc | Angiotech Pharmaceuticals, Inc. | FOZ | Class II | |
| K073376 | Philips ECG Algorithm | Philips North America LLC | LOS | ||
| K073106 | Unifast III | GC America Inc. | EBG | Class II | |
| K073058 | Rescue Internal Implant System | Megagen Co., Ltd. | DZE | Class II | |
| K072720 | Alimaxx-B Uncovered Biliary Stent System | Alveolus, Inc. | FGE | Class II | |
| K072460 | Hi-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular | DQX | Class II | |
| K080857 | Chromophare E-Series | Berchtold Holding GmbH | FSY | Class II | |
| K080850 | Darco Headless Compression Screw | Wrightmedicaltechnologyinc | HWC | Class II | |
| K080434 | Intertan Chs Locking Plate System Prox Fem Plates/screw | Smith & Nephew, Inc. | JDO | Class II | |
| K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | MAH | Class II | |
| K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen Lp Prolapse Repair System | American Medical Systems, Inc. | OTP | Class III | |
| K080163 | Cooltouch Models Lc215 and Coollipo | New Star Lasers, Inc. | GEX | Class II | |
| K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | MAX | Class II | |
| K073648 | Glucosure Star Blood Glucose Monitoring System, Model As90000e1 | Apex Biotechnology Corp. | CGA | Class II | |
| K073590 | Kronus Ia-2 Autoantibody Ria Assay Kit | Kronus Market Development Associates, Inc. | OIF | Class II | |
| K073219 | Wmt Collagen Dermal Matrix, 4 Cm X 7 Cm, Model 89Xm-4X07, Vmt Collagen Dermal Matrix, 6 Cm X 8 Cm, Model 89Xm-6X08 | American Medical Systems, Inc. | FTM | Class II | |
| K072458 | Gbi Tsh Neonatal Screening Kit | Golden Bridge International, Inc. | JLW | Class II | |
| K072041 | Bovie Ids-400 Electrosurgical Generator | Apyx Medical Corporation | GEI | Class II | |
| K071524 | Tcmnaturelmed, Healthcare, Bloodcare, Bo's Abdominal | Tcm World, Inc. | MQX | Class II | |
| K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | NUC | Class II | |
| K060387 | Physioflow System | Vasocom, Inc. | DSB | Class II | |
| K080917 | Iroot Sp | Innovative BioCeramix, Inc | KIF | Class II | |
| K080880 | Rtm and Oval | Next Mobility, LLC | IOR | Class I | |
| K080770 | Imagenmd with Imagenq | Cardiovascular Imaging Technologies, LLC | LLZ | Class II | |
| K080410 | Karl Storz Scb/conmed Esu Interface Module, Model 20091522 | Karl Storz Endoscopy-America, Inc. | ODA | Class II | |
| K080226 | Navicare -Watchchild Obstetrical Data Management System (Navicare -Watchchild), Model P2912 | Hill-Rom Manufacturing, Inc. | HGM | Class II | |
| K080132 | Thd Disposable Anoscope/proctoscope | Thd SpA | FER | Class II | |
| K080099 | Pass Spinal System | Medicrea Technologies | MNI | Class II | |
| K073695 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model Mct-1F8/f17 | J. Morita USA, Inc. | JAK | Class II | |
| K073617 | Pharaon Lipo | Osyris | GEX | Class II | |
| K073222 | Modification To:specialty Needles | Busse Hospital Disposables | BSP | Class II | |
| K080792 | K2m Cocr Rod | K2M, Inc | MNI | Class II | |
| K080663 | Profemur Lx Revision 5/8 Coated Hip Stem | Wrightmedicaltechnologyinc | KWA | Class III | |
| K080502 | Modification To:pilot Spinal System | Life Spine | MNI | Class II | |
| K080360 | Endologix Visiflex Dual Lumen Catheter | Endologix LLC | DQY | Class II | |
| K080325 | Igrok | Igrok, LLC | LLZ | Class II | |
| K080300 | Cutera Multimodal Cellulite Product (Cmmcd) | Cutera Inc | NUV | Class II | |
| K080182 | Zeno Pmma Disc | Wieland Dental + Technik GmbH & Co. KG | EBG | Class II | |
| K080079 | S8 Escape II | ResMed Corp | BZD | Class II | |
| K073696 | Veraviewepocs | J. Morita USA, Inc. | MUH | Class II |