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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K183142 | PathVisionXL | Faxitron Bioptics, LLC | MWP | Class II | |
| K182589 | BD Plastipak Syringe | Becton Dickinson & Co | FMF | Class II | |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Omron Healthcare Co., Ltd. | DXN | Class II | |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) | Medtronic, Inc. | GDW | Class II | |
| K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | NAY | Class II | |
| K182203 | JKH Stimulator Plus | JKH USA, LLC | NUH | Class II | |
| K181669 | ConvertX Biliary Stent System | Brightwater Medical | FGE | Class II | |
| K180337 | EUROPA Pedicle Screw System | Mirus, LLC | NKB | Class II | |
| DEN170044 | ClearMate | Thornhill Research Inc | QFB | Class II | |
| K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | MQB | Class II | |
| K190311 | BIOK7600 Flat Panel Detector | Biokinemetrics Inc. | MQB | Class II | |
| K190300 | BIOK7600W Wireless Flat Panel Detector | Biokinemetrics Inc. | MQB | Class II | |
| K190296 | GammaTile | GT Medical Technologies | KXK | Class II | |
| K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed | ConMed Corporation | GCJ | Class II | |
| K183492 | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional | Synthes (USA) Products LLC | FTM | Class II | |
| K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | Stryker Corp. | NRY | Class II | |
| K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | Stryker Corp. | DQY | Class II | |
| K183430 | Modular Spinal Fixation System | Life Spine | NKB | Class II | |
| K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MSX | Class II | |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products LLC | MQN | Class II | |
| K183026 | Wright Jones Fracture System | Wrightmedicaltechnologyinc | HWC | Class II | |
| K182920 | MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) | Mirus, LLC | MAX | Class II | |
| K182570 | Venture 0.014 Catheter | Vascular Solutions LLC | DQY | Class II | |
| K182502 | Alteon Acetabular Cup System | Exactech, Inc. | LPH | Class II | |
| K181668 | FasTouch Absorbable Fixation System | Via Surgical, Ltd. | GDW | Class II | |
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | Apyx Medical Corporation | GEI | Class II | |
| K183603 | INnate Cannulated Screw System | Exsomed Corp. | HWC | Class II | |
| K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | bioMerieux, Inc. | LON | Class II | |
| K183469 | Microlife Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | |
| K183446 | BioPlex 2200 Lyme Total | Bio-Rad Laboratories Inc. | LSR | Class II | |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision BioLogic Inc. | GGP | Class II | |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | GYC | Class II | |
| K183232 | Double ENDOBUTTON Fixation Device | Smith & Nephew, Inc. | HTN | Class II | |
| K183180 | Caiman 5 Maryland | Aesculap Inc | GEI | Class II | |
| K183176 | Endotoxin Activity Assay (EAA) | Spectral Medical Inc. | NGS | Class II | |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet | NKB | Class II | |
| K181610 | ActivOrtho Nitinol Compression Screw System | Activortho, Inc. | HWC | Class II | |
| K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | FMI | Class II | |
| DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | Hemosonics, LLC | QFR | Class II | |
| K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | Smith & Nephew, Inc. | HRS | Class II | |
| K183236 | Rotium Bioresorbable Wick | Nanofiber Solutions LLC | MAI | Class II | |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | DZJ | Class II | |
| K182553 | Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. | DQX | Class II | |
| K182313 | BoneTrust Implant System | Medical Instinct Deutschland GmbH | DZE | Class II | |
| K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs | Sri Trang Gloves (Thailand) Co., Ltd. | LZA | Class I | |
| K182013 | EasyInstruments | Agency for Medical Innovations Inc. | GEI | Class II | |
| K181823 | KardiaAI | AliveCor | DQK | Class II | |
| K190276 | Provident II Hip Stem | Globus Medical, Inc. | LPH | Class II | |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | GXI | Class II |