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 |
|---|---|---|---|---|---|
| K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA Inc | OVE | Class II | |
| K072817 | Echelon Titanium Hip System | Smith & Nephew, Inc. | LPH | Class II | |
| K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | Ethicon, Inc | OTP | Class III | |
| K081341 | Reinforced Catheter Introducer System (Rcis) | Merit Medical Systems, Inc. | DYB | Class II | |
| K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | GEX | Class II | |
| K081163 | Smartset Gmv Gentamicin Bone Cement | Depuy Orthopaedics Inc. | MBB | Class II | |
| K081155 | Smartset Mv Bone Cement | Depuy Orthopaedics Inc. | LOD | Class II | |
| K081084 | Colorise Rigid | Zhermack S.p.A. | ELW | Class II | |
| K080977 | 3 Ccd Endocam 5550 | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K080769 | Invos Cerebral/somatic Oximeter System, Model 5100C | Somanetics Corp. | MUD | Class II | |
| K080752 | Conceivex Latex-Free Semen Collector | Conceivex, Inc. | OBB | Class II | |
| K080726 | Calypso 4D Localization System | Calypso Medical Technologies, Inc. | IYE | Class II | |
| K080701 | Shimadzu Mobile X-Ray System Mobiledart Evolution | Shimadzu Corp. | IZL | Class II | |
| K080328 | Mps Acacia Enteral Feeding Tube | Mps Acacia | KNT | Class II | |
| K080165 | Smart Savers Powder Free Nitrile Examination Glove (Blue, White, Pink and Gray) | Platinum Glove Industries Sdn. Bhd. | LZA | Class I | |
| K080153 | Synthes (USA) Curvilinear Distraction System | Synthes (USA) Products LLC | MQN | Class II | |
| K080128 | Sm-Extra Wide (Rbm) Implant System | Dio Department Dsi, Inc. | DZE | Class II | |
| K073622 | Easy Grip Dental Implant System | T.F.I. System S.R.L | DZE | Class II | |
| K073217 | Inclusive Implant Abutments | Inclusive Dental Solutions | NHA | Class II | |
| K072749 | Sialo Balloon Dilatation Catheter | Sialo Technology, Ltd. | GCJ | Class II | |
| K071915 | CPAP Mask | Arcimed Laboratories, LLC | BZD | Class II | |
| K071130 | Heartrak Af | Universal Medical, Inc. | DXH | Class II | |
| K081251 | Modification to Aeskulisa Ds DNA G | Aesku Diagnostics | LSW | Class II | |
| K080738 | Dentron Sensor | Dentron Systems, LLC | EAP | Class II | |
| K080665 | Novolet | U.S. Safety Syringes Co., Inc. | FPA | Class II | |
| K080660 | IV Administration Set | U.S. Safety Syringes Co., Inc. | FPA | Class II | |
| K080575 | Corridor4dm | Invia | KPS | Class II | |
| K080549 | Durafinish All-Cure, Model S296 | Parkell, Inc. | EBD | Class II | |
| K080462 | Progenix Dbm Putty | Medtronic Sofamor Danek | NUN | Class II | |
| K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit | Boston Scientific Corporation | MSD | Class II | |
| K080385 | Cruiser Pp5500 Challenger Powered Wheelchair | E1 Ent., Inc. | ITI | Class II | |
| K080337 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Bp3mq1-2D | Microlife Corp. | DXN | Class II | |
| K080314 | Spinal USA Interbody Fusion Device | Spinal USA | MAX | Class II | |
| K080250 | Leksell Surgiplan, Model 1006947 | Elekta Instrument AB | HAW | Class II | |
| K080007 | Graduated Adapter with Clave | Abbott Medical | EZD | Class II | |
| K073411 | Liteduo | LIGHT INSTRUMENTS Ltd. | GEX | Class II | |
| K073312 | Osteotrans-Ot Screw | Takiron Co., Ltd. | HWC | Class II | |
| K073311 | Osteotrans-Ot Pin | Takiron Co., Ltd. | HTY | Class II | |
| K073177 | Pioneer Intervertebral Fusion Device System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MAX | Class II | |
| K081228 | Capsure Ps (R) Spine System | Spine Wave Inc | MNI | Class II | |
| K080998 | Doripenem 10Ug Bbl Sensi-Disc | Becton Dickinson & Co | JTN | Class II | |
| K080936 | Conformis Total Knee Repiar System (Itotal) Tibial Component: 6.0 Mm Thickness | ConforMIS, Inc. | JWH | Class II | |
| K080891 | Revolution 45Mhz Ivus Imaging Catheter | Volcano Corporation | OBJ | Class II | |
| K080759 | Thermoflash Lx-26 | Jxb Co. Ltd Guangzhou (China) | FLL | Class II | |
| K080750 | Browne Rapicide Glutaraldehyde Indicator | STERIS Corporation | JOJ | Class II | |
| K080607 | Calibrator for Automated Systems (C.f.a.s.) Proteins with Model 11355279160 | Roche Diagnostics GmbH | JIX | Class II | |
| K080238 | Masimo Rainbow Set Radical 7 Pulse Co-Oximeter, Masimo Rainbow Set Rad 87 Pulse Co-Oximeter | Masimo Corporation | DQA | Class II | |
| K073097 | Tutodent Dental Membrane | Tutogen Medical U.S., Inc. | NPL | Class II | |
| K081179 | Mammosite Cavity Evaluation Device | Hologic, Inc. | JAQ | Class II | |
| K081105 | Ge Lightspeed Ct750 Hd (Lightspeed 8.0) | GE Healthcare | JAK | Class II |