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 |
|---|---|---|---|---|---|
| K060636 | Palladium-103 Seed Implant Kits -Multiple | C.R. Bard Inc | KXK | Class II | |
| K060382 | Flo-Rite, Model 478-1; Flo-Rite II, Model 478-1; Simpulse II, Model 478-2S; Numatix, Model Ncd401; Simpulse, Model 478-1 | Ameriflo Corp. | NFB | Class II | |
| K060167 | Atria 3100, Atria 6100 | ZOLL Medical Corporation | DPS | Class II | |
| K060052 | Ge Lightspeed Xtra CT Scanner System | GE Healthcare | JAK | Class II | |
| K053610 | Abaris | Traxtal Technologies, Inc. | JAK | Class II | |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and Accessories | GE Healthcare | CBR | Class II | |
| K053356 | Modification to: Cic Pro Clinical Information Center Central Station | GE Medical Systems Information Technologies, Inc. | DXJ | Class II | |
| K053353 | Rescue Implant System | Megagen Co., Ltd. | DZE | Class II | |
| K053306 | Iview | Ondemandsoft | IYO | Class II | |
| K052947 | Source Production & Equipment Co, Inc., Model M-19 Ir-192 Brachytherapy Source | Source Production and Equipment Co., Inc. | JAQ | Class II | |
| K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | MIX | Class II | |
| K060804 | Collagran-Collagen Wound Dressing, Collagranag-Collagen W/silver Antimicrobial Wound Dressing | Covalon Technologies Inc. | FRO | Unclassified | |
| K060754 | Elecsys Tsh Calset W/models 04738551 | Roche Diagnostics GmbH | JIT | Class II | |
| K060736 | Smith & Nephew 6.5Mm and 8.0Mm Cannulated Screws | Smith & Nephew, Inc. | HWC | Class II | |
| K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation System | Endius, Inc. | KWP | Class II | |
| K060438 | Rhs | TORNIER Inc. | JDB | Class II | |
| K060356 | Conserve Plus Quadrafix Acetabular Shell | Wrightmedicaltechnologyinc | KWA | Class III | |
| K060177 | Kls Martin Rigid Fixation - Sterile | KLS-Martin L.P. | JEY | Class II | |
| K060025 | Slimplicity Anterior Cervical Plate System | Spinal USA | KWQ | Class II | |
| K060365 | Apexcal | Ivoclar Vivadent, Inc. | EJK | Class II | |
| K053568 | Bilisoft Phototherapy System | Lumitex Medical Devices, Inc. | LBI | Class II | |
| K052843 | Busse Hospital Disposables Needle Stick Block/cube | Busse Hospital Disposables | FMI | Class II | |
| K052817 | Eureka Infusion Pump, Models Eureka-Ip, Eureka-Lf | Universal Medical Technologies | FRN | Class II | |
| K060892 | Galileos | Sirona Dental Systems GmbH | MUH | Class II | |
| K060873 | Vanguard MRI Auxiliary Patient Table with 4 and 8 Channel Coil Array for Ge Signa Systems | Sentinelle Medical, Inc. | MOS | Class II | |
| K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | MQP | Class II | |
| K060696 | Acclaim Total Elbow System | Depuy Orthopaedics Inc. | JDC | Class II | |
| K060533 | Lenstec Intraocular Lens (IOL) Injection System | Lenstec, Inc. | MSS | Class I | |
| K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | JIT | Class II | |
| K060341 | Sherlock Tip Location System (Tls) | C.R. Bard Inc | FOZ | Class II | |
| K060257 | Bd Phoenix Automated Microbiology System - Cefoxitin - 0.5-64 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K060145 | Fds Intimate and Intimate Warming Lubricant | Alberto-Culver USA, Inc. | NUC | Class II | |
| K053577 | Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K053497 | Guava Ezcd4 System | Guava Technologies, Inc. | GKZ | Class II | |
| K053481 | Kelo-Cote Spray | Advanced Bio-Technologies, Inc. | MDA | Class I | |
| K051842 | Green Love Male Contraceptive (Condom) | Cupid Condom, Ltd. | HIS | Class II | |
| K051651 | G4, Model Igm-0004 | U. S. Diagnostics, Inc. | NBW | Class II | |
| K060921 | S2 Recon Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K060878 | Gelita-Spon Absorbable Gelatin Sponge, Usp | Curamedical, BV | KHJ | Class II | |
| K060777 | Smith & Nephew Model 660Hd Image Management System | Smith & Nephew, Inc. | GCJ | Class II | |
| K060748 | Modification to Xia 4.5 Spinal System | Howmedica Osteonics Corp | NKB | Class II | |
| K060688 | Hemosil Synthasil | Instrumentation Laboratory Co. | GFO | Class II | |
| K060570 | Hemoglobin Alc Control | Compass Bioscience | JJX | Class I | |
| K060445 | Norian Crs Bone Cement | Synthes (USA) Products LLC | GXP | Class II | |
| K060443 | Norian Crs Fast Set Putty | Synthes (USA) Products LLC | GXP | Class II | |
| K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock | Elcam Medical A.C.A.L. | FMG | Class II | |
| K053589 | Long-Term Hemodialysis Catheters with Biobloc Coating | Bard Access Systems, Inc. | MSD | Class II | |
| K053354 | Intermezzo Plus Fixture | Megagen Co., Ltd. | DZE | Class II | |
| K052457 | Picsi Sperm Selection Device | Biocoat, Inc. | MQK | Class II | |
| K060960 | Boston Scientific Talon Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II |