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 |
|---|---|---|---|---|---|
| K073348 | Lucent Magnum | Spinal Elements, Inc | MAX | Class II | |
| K073066 | 308 Dermatological Excimer System | Quantel Medical | FTC | Class II | |
| K072979 | Spirobank G | Mir Medical Intl. Research SRL | BZG | Class II | |
| K072791 | Oracle Spacer, Opal Spacer | Synthes GmbH | MAX | Class II | |
| K072788 | Storz Modulith Lithotripter Slx-F2-F180 | Karl Storz Endoscopy-America, Inc. | LNS | Class II | |
| K072261 | Finesse System | Primaeva Medical, Inc. | GEI | Class II | |
| K072231 | The Translation Plate Phase 1 (T-1 Plate) and Phase 2 (T-2 Plate) | Esm Technologies | KWQ | Class II | |
| K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide | Envisioneering, LLC | FCG | Class II | |
| K073199 | 3M Espe Lava Chairside Oral Scanner | Brontes Technologies | NOF | Class II | |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, Con | Siemens Healthcare Diagnostics Inc. | DBA | Class II | |
| K072886 | Medrad Stellant CT Injector System with P3t | Medrad, Inc. | DXT | Class II | |
| K072784 | Prodigy Autocode Blood Glucose Monitoring System, Model Td-4227, Clever Chek Td-4227 Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K072640 | Irispec,ca/cb/cc | International Remote Imaging Systems | JJW | Class I | |
| K072475 | Balder Finesse and Junior Powered Wheelchairs (with Stand-Up Option) | Etac Sverige AB | IPL | Class II | |
| K072407 | Bodyform Thoracic Fixation System | Theken Companies LLC | KWQ | Class II | |
| K072328 | Medtrade Products Celox Solbag, Anti - Coagulant | Medtrade Products Ltd. | QSY | Unclassified | |
| K072138 | Vidas C. Difficile Toxin A&b (Cdab) Assay, Model: 30 118 | bioMerieux, Inc. | LLH | Class I | |
| K072068 | Bioaquacare, Model C-10( Various Sizes) with and without Gauze, Blister Packaged or in Plastic Bag Containers | Bioartificial Gel Technologies (Bagtech), Inc. | FRO | Unclassified | |
| K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) | Disc-O-Tech Medical Technologies, Ltd. | NDN | Class II | |
| K070486 | Capillarys Urine (Pn 2012) | Sebia, Inc. | JKM | Class II | |
| K070458 | Modification to Fidis Vasculitis, Model Mx007 | Biomedical Diagnostics (Bmd) SA | MOB | Class II | |
| K063304 | Life4c | Numedis, Inc. | LYX | Unclassified | |
| K062580 | Ge Entropy Sensor (Refm1038681) and Ge Entropy Cable (Ref M1050784) | GE Healthcare | GXY | Class II | |
| K043617 | Imagechecker CT Cad Software System | Hologic, Inc. | OEB | Class II | |
| K073518 | Flashlite Rebel* | Discus Dental LLC | EBZ | Class II | |
| K073456 | T-Quest System | Medx, Inc. | IYX | Class I | |
| K073448 | Medical Display, Md205mg | Nec Display Solutions, Ltd. | LLZ | Class II | |
| K073400 | Varicath Peripheral Infusion Catheter | Veinrx, Inc. | KRA | Class II | |
| K073398 | Microlife Wrist Watch Blood Pressure Monitor, Model Bp3mk1-3 (Bp W100) | Microlife Corp. | DXN | Class II | |
| K073397 | Microlife Upper Arm Manual Blood Pressure Monitor, Model Bp3mr1-H (Bp A50) | Microlife Corp. | DXN | Class II | |
| K073325 | Legion Porous Primary | Smith & Nephew, Inc. | MBH | Class II | |
| K073304 | Cardica C-Port X-Change Anastomosis System and Handle and Xa X-Change Subassemblies | Cardica, Inc. | FZP | Class II | |
| K073259 | Xidf-100A/b1 Image Processor | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K073230 | Models Era 300 and 3105 Pacing System Analyzers | BIOTRONIK AG | DTA | Class II | |
| K073193 | Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Prosperous Plastic Co., Ltd. | LYZ | Class I | |
| K073175 | Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | HSX | Class II | |
| K073127 | Blood Collection Needle, Model 20G 21G 22G | ShanDong WeiGao Group Medical Polymer Co., Ltd | FMI | Class II | |
| K072980 | Nobelperfect Conical Connection Hexagonal Implants | Nobel Biocare AB | DZE | Class II | |
| K072976 | Model 250Cx Series Maternal/fetal Monitor | GE Healthcare | HGM | Class II | |
| K072764 | Kls Martin Xternal Fixator | KLS-Martin L.P. | MQN | Class II | |
| K072697 | 3T Blood Collection Cardiotomy Reservoirs and Accessories | 3T Medical Systems Inc. | DTN | Class II | |
| K072642 | Biomet 3I Dental Abutments and Restorative Components | ZimVie US Corp LLC | NHA | Class II | |
| K072631 | Jbaids Plaque Detection Kit, Model Jrpd-Asy-0123 | Idaho Technology, Inc. | NHT | Class II | |
| K072605 | Malibu Spinal System | Seaspine, Inc. | NKB | Class II | |
| K072599 | Plac Test Reagent Kit,calibrator Kit, Lp-Pla2 Control Kit, Model(s) 90107,90109,90109 | Diadexus, Inc. | NOE | Class II | |
| K072518 | Crs Fibrin Analysis Catheter Testing System (Facts) | Crs Medical Diagnostics, Inc. | LJS | Class II | |
| K072273 | Belmont Quolis 5000 Series Dental Unit | Takara Belmont USA, Inc. | NRD | Class I | |
| K071885 | Antimicrobial and Single-Patient Cuffs | Philips North America LLC | OED | Class II | |
| K071818 | Ensite Fusion Dynamic Registration Tool | Abbott Medical | DQK | Class II | |
| K071730 | Studiodop Vicorder | Skidmore Medical Limited | JOP | Class II |