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 |
|---|---|---|---|---|---|
| K091315 | Covidien Extended Tip Applicator | Confluent Surgical,Inc | FMF | Class II | |
| K090971 | Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay | Becton Dickinson & Co | LSL | Class II | |
| K090951 | Rs- Lb Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive Garment , Model Rs-Fbg | RS Medical | GXY | Class II | |
| K090933 | Bernhard-Forster Gmbh Orthodontic Ceramic Brackets | Forestadent Bernhard Forster GmbH | NJM | Class II | |
| K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | GZJ | Class II | |
| K090455 | Provox Vega, Model 8130-8135 | Atos Medical AB | EWL | Class II | |
| K090443 | Planet 55, Model 100 | Larsen & Toubro Limited | MHX | Class II | |
| K090397 | Xpi Angled Abutments | Keystone Dental Inc. | NHA | Class II | |
| K090284 | Res-Q Infant Wedge and Sling | Cr Enterprises, LLC | FRP | Class I | |
| K090283 | Calibrator 1,2, and 3 Models: Gen-Cal1, Gen-Cal2, and Gen-Cal3 | Genchem, Inc. | JIX | Class II | |
| K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 | Kai Sensors, Inc. | BZQ | Class II | |
| K090172 | Star 55 Model 100 | Larsen & Toubro Limited | MHX | Class II | |
| K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | DRG | Class II | |
| K083723 | A6 Luer Access Device | B.Braun Medical, Inc. | FPA | Class II | |
| K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | GEI | Class II | |
| K083195 | Mach 4 Jet Tooth Shade Provisonal Crown and Bridge Acrylic Resin | Lang Dental Mfg Co, Inc. | EBG | Class II | |
| K083158 | Exalis, Software Version 1.15 | Gambro, Inc. | KDI | Class II | |
| K080108 | Cortoss Bone Augmentation Material | DSM Biomedical, Inc. | NDN | Class II | |
| K091368 | R2 Digitalnow Hd(digitalnow Hd) | Hologic, Inc. | LLZ | Class II | |
| K091323 | Modified Intermedic Diode Laser 980Nm System (Multidiode Sst 200) | Intermedic Arfran, S.A. | GEX | Class II | |
| K091253 | Thoracolumbar Plate, Model 1208-41Fxx, Lumber Plate, Model 1208-41Fxxl, Sacral Plate, Model 1208-41Fxxs | K2M, Inc | KWQ | Class II | |
| K091019 | Speedcem | Ivoclar Vivadent, Inc. | EMA | Class II | |
| K090968 | Sensititre Yeastone Susceptibility Plates | Trek Diagnostic Systems, Ltd. | NGZ | Class II | |
| K090938 | Flow Controller | Odyssey Medical, Inc. | LZU | Unclassified | |
| K090909 | C-Qur V -Patch Mesh | Atrium Medical Corporation | FTL | Class II | |
| K090772 | Fully Automatic Electronc Blood Pressure Monitor, Model Kd-5903, Kd-5909 | Andon Health Co., Ltd | DXN | Class II | |
| K090771 | Fully Automatic Electronc Blood Pressure Monitor, Model, Kd-5962 | Andon Health Co., Ltd | DXN | Class II | |
| K090770 | Fully Automatic Electronc Blood Pressure Monitor, Model Kd-5905 | Andon Health Co., Ltd | DXN | Class II | |
| K090769 | Fully Automatic Electronic Blood Pressure Monitor, Model Kd-7961 | Andon Health Co., Ltd | DXN | Class II | |
| K090768 | Fully Automatic Electronic Blood Pressure Monitor, Models Kd 5901, Kd-7909, | Andon Health Co., Ltd | DXN | Class II | |
| K090675 | Smith & Nephew, Inc. Vlp Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | HRS | Class II | |
| K090629 | Easy Step and Diachex+ Pro Blood Glucose Monitoring Systems | Tyson Bioresearch, Inc. | NBW | Class II | |
| K090611 | Revolution Full Core Biopsy | Inrad | KNW | Class II | |
| K090114 | Modification To:introducer Sets, Model Adelante and Adelante-S | Oscor Inc. | DYB | Class II | |
| K083772 | Columbus Revision Knee System | Aesculap Implant System, Inc. | JWH | Class II | |
| K081410 | Option Vena Cava Filter | Rex Medical LP | DTK | Class II | |
| K090737 | Hemoglobin Capillary Collection System (Hccs), 1 Test, Hemoglobin Capillary Collection System (Hccs), 5 Tests, Hemoglobi | Bio-Rad Laboratories Inc. | JKA | Class II | |
| K090656 | Intertan Chs Limited Collapse Set Screw | Smith & Nephew, Inc. | HWC | Class II | |
| K090615 | Opus Speedlock Knotless Fixation Device | ArthroCare Corporation | MBI | Class II | |
| K090367 | Se-601 Series Electrocardiograph | Edan Instruments, Inc. | DPS | Class II | |
| K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model Sw-2013, Level 1 Snuggle Warm Left Lateral | Abbott Medical | DWJ | Class II | |
| K091346 | Codman Hakim Micro II Valve | Cerenovus, Inc. | JXG | Class II | |
| K090934 | Pfr Sling System, Part of the Ams Pelvic Floor Repair System | American Medical Systems, Inc. | FTL | Class II | |
| K090907 | Penta Lead Kits, Models: 3227-3234 | Abbott Medical | GZB | Class II | |
| K090824 | Bd Probetec Chlamydia Trachomatis (CT) Qx Amplified DNA Assay | Becton Dickinson & Co | MKZ | Class I | |
| K090776 | Megapulse Laser System and Fibers | Richard Wolf Medical Instruments Corp. | GEX | Class II | |
| K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication) | Nobel Biocare AB | FZE | Class II | |
| K090430 | Backstop and Backstop Injector | Pluromed, Inc. | ONJ | Class II | |
| K090209 | Hemosil Liquid Heparin, Heparin Calibrators and Lmw and Uf Heparin Controls | Instrumentation Laboratory Co. | KFF | Class II | |
| K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified |