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 |
|---|---|---|---|---|---|
| K070112 | Rapidcool Patient Temperature Management System | Medcool, Inc. | DWJ | Class II | |
| K063805 | Silcryst Silver Antimicrobial Wound Cream, Model a-00901 | Nucryst Pharmaceuticals, Inc. | FRO | Unclassified | |
| K063641 | Pc-60, Non-Invasivepulse Oximeter | Shenzhen Creative Industry Co., Ltd | DQA | Class II | |
| K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | FRO | Unclassified | |
| K062981 | I-Chroma Crp Test | Boditech Diagnostics, Inc. | DCN | Class II | |
| K062118 | Pointe 360 | Horiba Instruments Incorporated | CFR | Class II | |
| K071640 | Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-Vvdc-02-Abrm | Cook Inc. | NHC | Class II | |
| K071634 | Modification To:contour Se Microspheres | Boston Scientific Corporation | HCG | Class II | |
| K071473 | Modification to Superdimension/bronchus Premium 2 | Medtronic, Inc. | EOQ | Class II | |
| K071285 | Digital Pulse Oximeter, Model 7500 | Nonin Medical, Inc | DQA | Class II | |
| K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | FRO | Unclassified | |
| K071725 | M2 Monitor | Spectrum Medical Inc | DRY | Class II | |
| K071630 | Terumo 31G Thinpro Insulin Syringe | Terumo Medical Corp. | FMF | Class II | |
| K071599 | Easyguide | Keystone Dental Inc. | LLZ | Class II | |
| K071585 | P.004 Healing Abutments and Closure Screws | Straumann USA, LLC | NHA | Class II | |
| K071581 | Backpack Medical Oxygen System | Essex Cryogenics of Missouri, Inc. | BYJ | Class II | |
| K071227 | Clirpath Turbo Excimer Laser Catheter (Rx) -0.9Mm, (Rx) -1.4Mm, (Rx) -1.7Mm, (Rx) -2.0Mm, Model 310-154, 314-159, 317-15 | Spectranetics Corp. | PDU | Class II | |
| K071182 | Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 to 30-4013 | Nobel Biocare AB | ELL | Class II | |
| K070960 | Nova Statstrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | CGA | Class II | |
| K070805 | Ultrawave II Ex 1320 | Quanta System Inc. | GEX | Class II | |
| K070785 | Dynasty Acetabular System | Wrightmedicaltechnologyinc | JDL | Class III | |
| K070634 | Soyee Portable X-Ray Unit, Model Sy-HF-110 | Soyee Product, Inc. | IZL | Class II | |
| K070611 | Bat Ultrasound Localization and Positioning System, Version 6 | Nomos Corp. | IYE | Class II | |
| K070578 | Clinical Thermometer/model Zsdt-Xxxx Digital Thermometer and Zset-Xxx Infrared Thermometer | Zen Strong Medical Technology Co., Ltd. | FLL | Class II | |
| K070401 | Endo-Chx | Essential Dental Systems, Inc. | KJJ | Unclassified | |
| K070377 | Giraffe and Panda Warmer | GE Healthcare | FMT | Class II | |
| K070253 | Axya Suture Welding System and Kit | TORNIER Inc. | GAT | Class II | |
| K071629 | Parietex Polyester Mesh with Introducer | Sofradim Production | FTL | Class II | |
| K071171 | Vpap Auto with H3i | ResMed Corp | BZD | Class II | |
| K070794 | Atlantik | Medical Biomat | MQV | Class II | |
| K070333 | Acryderm Silver Antimicrobial OTC Wound Gel | Acrymed, Inc. | FRO | Unclassified | |
| K070293 | Benvenue Vcf Osteo Coil System | Benvenue Medical, Inc. | OCJ | Class I | |
| K063772 | Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K063357 | Minicollect Capillary Blood Collection Tubes | Greiner Bio-One North America, Inc. | JKA | Class II | |
| K063154 | Facial Reconstructive Mesh (Frm) | Evera Medical, Inc. | FTL | Class II | |
| K062331 | Highpak-12 | Ad Elektronik GmbH | MPD | Class II | |
| K071639 | Qwix Positioning Screw | Newdeal SAS | HWC | Class II | |
| K071534 | Confirma Breast MRI Interventional Components | Confirma, Inc. | MOS | Class II | |
| K071452 | Fl Bond II | Shofu Dental Corp. | KLE | Class II | |
| K071395 | Biomet Vision Footring System | Biomet Manufacturing Corp | KTT | Class II | |
| K071264 | Synthes (USA) 2.4/2.7 Mm Locking Foot Module | Synthes (USA) Products LLC | HRS | Class II | |
| K070732 | Bci Autocon 3304 Digital Pulse Oximeter | Abbott Medical | DQA | Class II | |
| K071870 | Hexapod Rt Couch Top | 3C-Medical Intelligence GmbH | JAI | Class II | |
| K071743 | Pillar Pedicle Screw System | The 4th Column, LLC | MNI | Class II | |
| K071698 | Aurora LED Series Surgical Lights | Skytron, LLC | FSY | Class II | |
| K071318 | Modification to: Stockert S5 System | LivaNova Deutschland GmbH | DTQ | Class II | |
| K071107 | Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution Cr-Flex Gender Solutions Female Femoral Compon | Zimmer GmbH | MBH | Class II | |
| K070915 | Sapimed Disposable Sigmoidoscope | Sapimed S.p.A. | KDM | Class II | |
| K062616 | Wellnesspro 2010 | Intelsource Group, Inc. | GZJ | Class II | |
| K071717 | Ge Oec Altitude | Shimadzu Corp. | IZI | Class II |