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 |
|---|---|---|---|---|---|
| K062900 | Pajunks Stimulong Tsui-Method Set | Pajunk GmbH Medizintechnologie | CAZ | Class II | |
| K062800 | Clever Chek Td-3213/ Clever Chek Td-3215/ Dr. T Td-3216/ Clever Chek Td-3217/ Clever Chek Td-3250 Blood Glucose Plus Blo | Taidoc Technology Corporation | NBW | Class II | |
| K062759 | Paramount Vbr System | Innovative Spinal Technologies, Inc. | MQP | Class II | |
| K062670 | Vertiflex Spinal Screw System | Vertiflex (Tm), Incorporated | MNH | Class II | |
| K061678 | Prorhythm Promap Coaxial Mapping Catheter, Models Pri-Map-15, Pri-Map-20, Pri-Map-25 | Prorhythm | DRF | Class II | |
| K061431 | Easygluco, Model Igm-0002 G2 | U. S. Diagnostics, Inc. | CGA | Class II | |
| K061430 | System 83 Plus Miniflex Washer-Disinfector | Wassenburg Medical B.V. | FEB | Class II | |
| K060272 | Locobase Wound and Skin Emulsion | Ferndale Laboratories, Inc. | FRO | Unclassified | |
| K063644 | Cardica C-Port Xa Distal Anastomosis System | Cardica, Inc. | FZP | Class II | |
| K063623 | Vitek 2 Gram Positive Meropenem for Streptococcus Pneumoniae | bioMerieux, Inc. | LON | Class II | |
| K063610 | Dimension Vista A1at Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium and High | Siemens Healthcare Diagnostics Inc. | DEM | Class II | |
| K063573 | Bd Phoenix Automated Microbiology System-Ceftazidime (Gn) 0.5-64 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K063375 | Heartstart Mrx, Models M3535a or M3536a | Philips North America LLC | MKJ | Class III | |
| K063255 | D130 Ph.i.s.i.o Dideco Kids Neonatal Arterial Filter with 40 Micron Screen Phosphorylcholine Coated | Corcym Inc. | DTM | Class II | |
| K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | EHD | Class II | |
| K070007 | Spi Element Platform O 4.0 Mm | Thommen Medical AG | DZE | Class II | |
| K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC. | HIF | Class II | |
| K062176 | Relief Acp Oral Care Gel | Discus Dental LLC | LBH | Class II | |
| K061613 | Ventana Image Analysis System - Pathway Her2 (4B5) | Becton Dickinson & Co | NQN | Class II | |
| K063587 | Xodus Medical Anti-Fog Solution | Xodus Medical Inc | OCT | Class II | |
| K063456 | Srt100 Superficial Radiation Therapy System | Topex, Inc. | JAD | Class II | |
| K063151 | Humapen Luxura Hd | Eli Lilly and Company, Pharmaceutical Delivery Systems | NSC | Class II | |
| K062907 | Alexis Wound Retractor | Applied Medical Resources Corp | KGW | Class II | |
| K063406 | Encore Knee System Ifu | Encore Medical, LP | JWH | Class II | |
| K063405 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | NCX | Class II | |
| K063103 | Ag-Edge, Model 91200 | Medel S.p.A. | CAF | Class II | |
| K062937 | Transdiscal System, Models Tdp-17-150-6, Tdi-17-150, Tda-Ppu-1, Tda-Tbk-1, Tdx-Y-Tsw-Tdp, Tdx-Pmg-Ppu | Baylis Medical Co., Inc. | GXI | Class II | |
| K062553 | Simplex P Bone Cement | Stryker Orthopaedics | LOD | Class II | |
| K062439 | Powertone, Model Pt-11 | Johari Digital Healthcare, Ltd. | NGX | Class II | |
| K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound di | IYN | Class II | |
| K063799 | Steamplus Steam Integrator | Spsmedical Supply Corp. | JOJ | Class II | |
| K063781 | Philips Xd-S Direct Radiography Workstation/package | Philips North America LLC | LLZ | Class II | |
| K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | JAK | Class II | |
| K063718 | Sfb and Cfb Implants - 5.0 Platform | Nobel Biocare AB | DZE | Class II | |
| K063677 | Fusion Quattro Extraction Balloon Xl | Wilson-Cook Medical Inc. | GCA | Class II | |
| K063632 | X-Force N30 Nephrostomy Balloon Dilation Catheter | C.R. Bard Inc | LJE | Unclassified | |
| K063560 | Hilger Dual-Stim Nerve Stimulator | WR Medical Electronics Co. | ETN | Class II | |
| K063529 | Pencure, Model Vl-7 | J. Morita USA, Inc. | EBZ | Class II | |
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and Cs300 Intra-Aortic Balloon Pump Control System | Datascope Corp. | DSP | Class II | |
| K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | LLZ | Class II | |
| K063181 | Synthes (USA) Condylar Head Add-on System | Synthes (USA) Products LLC | NEI | Class II | |
| K062780 | Clickzip, Model U-100 Insulin Safety Syringe | Medical Device Manufacturer (Thailand), Ltd. | MEG | Class II | |
| K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions LLC | DQO | Class II | |
| K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; Fs Calibrator 1; Dat Performance Verifiers | Ortho-Clinical Diagnostics, Inc. | DIS | Class II | |
| K060415 | Modification to: Satellite Spinal System | Medtronic Sofamor Danek | NVR | Class III | |
| K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K063709 | Ts-Bone Hip Tool | Orthopedic Sciences, Inc | HRS | Class II | |
| K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5 | Philips North America LLC | LNH | Class II | |
| K063509 | Depuy Peak Fx Hip Plate | Depuy Orthopaedics Inc. | KTT | Class II | |
| K063338 | Hearid+te Transient-Evoked Otoacoustic Emissions Analyzer | Mimosa Acoustics, Inc. | EWO | Class II |