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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K140045 | Body Composition Analyzer | Jawon Medical Co., Ltd. | MNW | Class II | |
| K150105 | Klassic Knee System-Sombrero Patella | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K143337 | CONELOG Titanium base CAD/CAM | Altatec GmbH | NHA | Class II | |
| K143183 | Maxima XTEND Handpiece Maintenance System | Handpiece Headquarters | EFB | Class I | |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | BioFire Diagnostics, LLC | OCC | Class II | |
| K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA | Life Global Group, LLC | MQL | Class II | |
| K142476 | Master Caution Device MCD | Healthwatch | DXH | Class II | |
| K141738 | Medeor Matrix Wound Dressing | Kensey Nash Corporation dba Dsm Biomedical | KGN | Unclassified | |
| K140913 | Nuros Bone Graft Substitute | Oriental Resources Development Limited | MQV | Class II | |
| K150122 | Tomtec-Arena Tta2 | TOMTEC Imaging Systems GmbH | LLZ | Class II | |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | Bausch & Lomb Incorporated | LPL | Class II | |
| K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style | Dispo-Med (Malaysia) Sdn Bhd | CCK | Class II | |
| K143058 | PuraDerm Gel | 3-D Matrix, Inc. | FRO | Unclassified | |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family | Shaser, Inc. | GEX | Class II | |
| K142881 | DMRC Dual Cure Orthodontic Band Cement | Danville Materials, Inc. | DYH | Class II | |
| K142775 | Neuwater TM (HydrocynTM aqua) | Vigilenz Medical Devices | FRO | Unclassified | |
| K142374 | ivWatch Model 400 | Ivwatch, LLC | MRZ | Class II | |
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff | Medtronic, Inc. | JOH | Class II | |
| K142156 | Seegene Anyplex II Hsv-1/2 Assay | Seegene Inc. | OQO | Class II | |
| K142064 | Galileo Nt | EB Neuro S.p.A. | OLT | Class II | |
| K141946 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | DPS | Class II | |
| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250 | Phadia AB | DBM | Class II | |
| K141316 | Cognision Eeg/ep System | Neuronetrix Solutions, LLC | OLT | Class II | |
| K141274 | Quanta Flash ¿2Gp1-Domain1; Controls, Hemosil Acustar Anti-¿2Gpi Domain1; Controls. | Inova Diagnostics, Inc. | MSV | Class II | |
| K141205 | Lzi Oral Fluid 6-Acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-Acetylmorphine Calibrators (5 Ml), Lzi Oral Fluid 6 | Lin-Zhi International Inc | DJG | Class II | |
| K140881 | Depuy Attune Knee System - Cementless Cr and Ps Femoral Componenets | Depuy (Ireland) | MBH | Class II | |
| K143628 | Navigated Vertex Select Instruments | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K143569 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K143469 | SOFTECH Plus ETCO2 Cannula | Teleflexmedical, Inc. | CCK | Class II | |
| K143377 | PedFuse Pedicle Screw System | SPINEFRONTIER, Inc. dba LESspine Innovations | MNH | Class II | |
| K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | Cepheid | PEU | Class II | |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | Zimmer Spine, Inc. | MAX | Class II | |
| K143226 | Visionaire Disposable Instruments | Smith & Nephew, Inc. | JWH | Class II | |
| K143192 | Vanguard 360 Revision Knee System | Zimmer GmbH | JWH | Class II | |
| K143131 | Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile | Kossan International Sdn Bhd | LZA | Class I | |
| K143055 | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple, Peppermint, Vanilla | Yty Industry (Manjung) Sdn. Bhd. | LZA | Class I | |
| K141803 | Immunalysis Tramadol Urine Enzyme Immunoassay | Immunalysis Corporation | DJG | Class II | |
| K141328 | Quanta Flash Ro60, Quanta Flash Ro60 Calibrators, Quanta Flash Ro60 Controls | Inova Diagnostics, Inc. | LLL | Class II | |
| K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine | NKB | Class II | |
| K141087 | Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled Hmef | Intersurgical Incorporated | CAH | Class II | |
| K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | KRO | Class II | |
| K134046 | Fukuda Denshi Dynascope Model Ds-8100N/8100m Patient Monitor | Fukuda Denshi USA, Inc. | MHX | Class II | |
| K133268 | Tizian Blank, Tizian Zirconium Reinforced Composite Blank, Tizian Color Blank, Tizian Blank Occlusal, Tizian Blank Trans | Schutz-Dental GmbH | EBG | Class II | |
| DEN140020 | Eclipse System | Pelvalon | PJH | Class II | |
| K150178 | Cd Horizon Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K143092 | Tensyn Plug | Dallen Medical, Inc. | HTN | Class II | |
| K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | EIH | Class II | |
| K142685 | Nitrile Examination Gloves with Aloe & Vitamin E, Powder- Free | Siam Sempermed Corp., Ltd. | LZA | Class I | |
| K150092 | STERISPINE PS Pedicle Screw | Safe Orthopaedics | NKB | Class II |