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 |
|---|---|---|---|---|---|
| K072812 | Philips Heartstart Smartpads III | Philips North America LLC | MKJ | Class III | |
| K072145 | Medical Glove Series | Zhanjiang Jiali Glove Products Co., Ltd. | LYY | Class I | |
| K072055 | Lava Frame, Lava Frame Shade | 3M Espe AG Dental Products | NHA | Class II | |
| K073646 | Minitape Urethral Sling | Mpathy Medical Devices, Ltd. | PAH | Class II | |
| K073046 | Ethicon Endo Surgery Articulating Needle Knife, Model 2504 | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K073036 | Fore-Sight, Mc-2000 Series | Cas Medical Systems, Inc. | DQA | Class II | |
| K072860 | Ya Horng Digital Upper Arm Blood Pressure Monitor, Bp-100J, Bp-110J; Digital Wrist Blood Pressure Monitor, Bp-500,Bp-500 | Ya Horng Electronic Co., Ltd. | DXN | Class II | |
| K070961 | Biomerix Surgical Mesh, Model: Rcr-01 | Biomerix Corporation | FTL | Class II | |
| K080367 | Zimmer Mis Light | Zimmer Spine, Inc. | FST | Class II | |
| K080333 | Imagegrid | Candelis, Inc. | LLZ | Class II | |
| K080290 | Xviewnet | American Radiologist Network, Inc. | LLZ | Class II | |
| K073596 | Neomed Single Lumen Umbilical Catheter | Halyard Health | FOS | Class II | |
| K073576 | Neurosurgical Sponges and Paddles and Neuro Patties and Neurosponges | Harod Enterprises, Inc. | HBA | Class II | |
| K073466 | Smith & Nephew Intradiscal Catheter System | Smith & Nephew, Inc. | GEI | Class II | |
| K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C. Laser GmbH | GEX | Class II | |
| K072129 | Nobelactive Zirconia Abutment | Nobel Biocare AB | NHA | Class II | |
| K071896 | Fox 940, Model 940 | Valam, Inc. | GEX | Class II | |
| K071490 | Leone Orthodontic Mini Implant | Leone S.p.A. | OAT | Class II | |
| K062763 | Noncon Robo Pachy F&a | Konan Medical, Inc. | NQE | Class II | |
| K080334 | Instarad | Medsphere Technologies Pvt, Ltd. | LLZ | Class II | |
| K080320 | Primevue 21 3Mp Color Display, Model Ac-Qx21-A9300 | NDS Surgical Imaging, LLC | LLZ | Class II | |
| K080119 | Clearscan | Esi, Inc. | ITX | Class II | |
| K073704 | I-Dixel | J. Morita USA, Inc. | LLZ | Class II | |
| K073570 | Depuy Tri-Lock Bone Preservation Stem | Depuy Orthopaedics Inc. | LZO | Class II | |
| K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular | Medtronic, Inc. | BSP | Class II | |
| K073460 | Synthes 2.7 Mm/3.5 Mm Lcp Distal Fibula Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K073375 | Newdeal Tibiaxys System | Newdeal SAS | HRS | Class II | |
| K073314 | Heany Industries Inc Dental Xirconia | Heany Industries, Inc. | EIH | Class II | |
| K073184 | Boston Rgp Lenses Wet Shipped in Bostom Simplus Multi-Action Solution and Stored for Up to 30 Days | Bausch & Lomb Incorporated | HQD | Class II | |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: Df48b | Siemens Healthcare Diagnostics Inc. | JHM | Class I | |
| K073065 | Osteomed Metatarsal Resurfacing Implant System | Osteomed | KWD | Class II | |
| K072988 | Nipro Transducer Protector Tp-Sure, Model Tpsure+1 | Nipro Medical Corporation | FIB | Class II | |
| K072223 | Vinyl Examination Glove, Powdered | Pinnacle Co., Ltd | LYZ | Class I | |
| K072158 | Aqua Pure Deionizer Exchange Service | Staubach Barror Water Systems Inc. | FIP | Class II | |
| K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | HRS | Class II | |
| K070259 | Ec50 Toxco+ Breath Carbon Monoxide Monitor | Bedfont Scientific Ltd. | CCJ | Class II | |
| K073283 | Gc Gam-100 | GC America Inc. | EMA | Class II | |
| K073232 | Indus Anterior Cervical Plate System, Model Im3xxx | SPINEFRONTIER, Inc. dba LESspine Innovations | KWQ | Class II | |
| K072851 | Polystar 79 Denture Base Resin | Cmp Industries, LLC | EBI | Class II | |
| K072821 | Vitrea 4Dct | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K072249 | Easyra Cholesterol Reagent; Easyra Calcium Reagent Reagent | Medica Corp. | CHH | Class I | |
| K073426 | Aperfix Interference Screw 7-12 Mm X 20 Mm; 7-12 Mm X 25 Mm; 7-12 Mm X 30 Mm | Cayenne Medical Inc. | HWC | Class II | |
| K073344 | Orthopediatrics Plating System | Orthopediatrics Corp | HRS | Class II | |
| K073331 | Dvo Extended Articulation Humeral Heads | Dvo Extremity Solutions, LLC | HSD | Class II | |
| K072704 | Unicompartmental Knee | Valpo Orthopedic Technology, Inc. | HRY | Class II | |
| K071532 | Alpha Infusion Pump, Model A200, A450 | Advanced Infusion, Inc. | MEB | Class II | |
| K080288 | Travel Pal Four Wheel Scooter, Model Mm114 | Mega Motion, Inc. | INI | Class II | |
| K080282 | Arthrocare Controllers (System 2000,1100,1200), Model H2076-00, H2079-00, H3000-00, H4000-00; | ArthroCare Corporation | GEI | Class II | |
| K080114 | Huayi H035 Basic Wheelchair | Danyang Huayi Medical Supply & Equipment Co, Ltd | IOR | Class I | |
| K080113 | Apex Dal Electronic Apex Locator | Medicnrg, Ltd. | LQY | Unclassified |