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 |
|---|---|---|---|---|---|
| K021163 | Octeia 25-Hydroxy Vitamin D | Immunodiagnostic Systems Ltd. | MRG | Class II | |
| K021105 | Fortaflex Surgical Mesh | Organogenesis, Inc. | FTM | Class II | |
| K020763 | Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit) | Lin-Zhi International Inc | DIO | Class II | |
| K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55Mm, 30Mm with Blue and Green Reload Cartridges | Power Medical Interventions, Inc. | GDW | Class II | |
| K020692 | Emit 2000 Vancomycin Assay | Siemens Healthcare Diagnostics Inc. | LEH | Class II | |
| K020617 | Nsi Hexed and Non-Hexed Implant System | Nsi | DZE | Class II | |
| K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K020449 | Cardionow Cardiology Wide Area Archive and Retrieval System | Cardionow, Inc. | LLZ | Class II | |
| K020445 | The Electrode Store Surface (Cutaneous) Electrode for EMG | The Electrode Store | GXY | Class II | |
| K020254 | Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011 | Lin-Zhi International Inc | LCM | Unclassified | |
| K013886 | Avera Model Dei System (Diffractive Energy Imaging System) | Advanced Diagnostics, Inc. | NCS | Class II | |
| K021339 | Haemophilus/streptococcus Pneumoniae | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K021166 | Acmi Bipolar Rectoscope, Model Eiwe-Br | Acmi-Circon Corporation | FDC | Class II | |
| K021135 | Model 2120Is Series Maternal/fetal Monitor | GE Medical Systems Information Technologies, Inc. | HGM | Class II | |
| K021054 | Codonics Horizon Ci Medical Multimedia Dry Imager; Codonics Horizon Gs Medical Multimedia Grey Scale Dry Imager | Codonics, Inc. | LMC | Class II | |
| K020944 | Vortex Valved Holding Chamber | Pari Innovative Manufacturers, Inc. | CAF | Class II | |
| K020820 | Microscan Microstep Plus Panel New Antimicrobial - Cefuroxime | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K020762 | Gatifloxin | Trek Diagnostic Systems, Ltd. | JWY | Class II | |
| K020724 | Dimension Automated Ldl Cholesterol Flex Reagentcartridge Method, Model Df131 | Siemens Healthcare Diagnostics Inc. | MRR | Class I | |
| K020709 | Modification to Cd Horizon Spinal System | Medtronic Sofamor Danek | KWP | Class II | |
| K020566 | Fujirebio Diagnostics Ca 19-9 Ria | Fujirebio Diagnostics, Inc. | NIG | Class II | |
| K020561 | Sono-Scan, Sono-Scan Pro, Cardio Scan | TOMTEC Imaging Systems GmbH | IYO | Class II | |
| K020547 | Ohmeda Medical Giraffe Incubator | GE Healthcare | FMZ | Class II | |
| K020543 | Ohmeda Medical Giraffe Omnibed | GE Healthcare | FMZ | Class II | |
| K020535 | Interlude and Other Private Label Plastic Applicator Tampons | Rostam, Ltd. | HEB | Class II | |
| K020430 | Diatek Connector Assembly Replacement Kit (Cark) | Diatek, Inc. | NFK | Class II | |
| K013855 | Microjet Crono H | Cane S.R.I. | FRN | Class II | |
| K013053 | Modification to Nanma Non-Adjustable Constriction Ring | Nanma Mfg Co., Ltd. | LKY | Class II | |
| K012132 | Chromagen V3.0 Reading Aid Soft Contact Lens | Cantor & Nissel, Ltd. | NIC | Class II | |
| K021410 | Aquasil Ultra Xlv Smart Wetting Impression Material | Dentsply Intl. | ELW | Class II | |
| K021300 | Modification of Philips Component Compact Monitor, Release A.03, Model M1275b | Philips North America LLC | DSI | Class II | |
| K021171 | Q-Stress Echo Bed | Medical Positioning Inc | DPS | Class II | |
| K021148 | Monarch Spine System Commercially Pure Titanium Spinal Rod | Depuyacromed | MNH | Class II | |
| K021102 | Dm Sleeve | Emily Iker M.D., A.P.C. | DWL | Class II | |
| K021090 | Oximax N-550 Pulse Oximeter,model N-550 Pulse Oximeter | Medtronic, Inc. | DQA | Class II | |
| K021065 | Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/gm Protein Claim | Primus Gloves Private Ltd. | KGO | Class I | |
| K020865 | Online Powder Free, Latex Examination Gloves | Apl Products Sdn. Bhd. | LYY | Class I | |
| K020845 | Emit 2000 Vancomycin Calibrators | Siemens Healthcare Diagnostics Inc. | DLJ | Class II | |
| K020822 | Microscan Microstep Plus Panel New Antimicrobial - Vancomycin | Siemens Healthcare Diagnostics Inc. | JWY | Class II | |
| K020788 | Wilson-Cook Zilver Biliary Stent | Wilson-Cook Medical Inc. | FGE | Class II | |
| K020723 | Dimension Aldl Calibrator, Model Dc131 | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K020634 | Modification to Atrium Medical Corporation Clearway PTFE Balloon Catheter | Atrium Medical Corporation | DXE | Class II | |
| K020466 | Hec 1000 | Metro Medical Equipment, Inc. | KPJ | Class II | |
| K020401 | Synthes Calcaneal Plate | Synthes (USA) Products LLC | HRS | Class II | |
| K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device | Acon Laboratories, Inc. | DKZ | Class II | |
| K020203 | Padpro Model #2516 | Padpro, LLC | MKJ | Class III | |
| K013822 | Microjet Crono Pca | Cane S.r.l. | MEA | Class II | |
| K013376 | Qflow 500 Perfusion Monitoring System | Hemedex Incorporated | DPW | Class II | |
| K012979 | Compressible Limb Sleeve | Medical Device Services | JOW | Class II | |
| K012712 | Norav Holter System, Model Nh-300 V1.07 | Norav Medical Ltd. | MLO | Class II |