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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K170910 | Medacta Anatomic Shoulder Prosthesis | Medacta International SA | KWS | Class II | |
| K170064 | GLUCOCARD W Blood Glucose Monitoring System | ARKRAY Factory, Inc. | NBW | Class II | |
| K163568 | Shofu Resin Glaze | Shofu Dental Corp. | EBD | Class II | |
| K162768 | ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables | Integral Process SAS | DSA | Class II | |
| K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K172163 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | MUJ | Class II | |
| K171162 | Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield | Prestige Ameritech | FXX | Class II | |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | Cair LGL | FPA | Class II | |
| K170872 | Aisys CS2 | GE Healthcare | BSZ | Class II | |
| K170222 | Rapid Tox Cup II | American Bio Medica Corp. | LAF | Class II | |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | Carolina Liquid Chemistries | DIO | Class II | |
| K163483 | PANA SPRAY Plus | Nakanishi Inc. | EFB | Class I | |
| K171332 | Artemis Neuro Evacuation Device | Penumbra Inc. | GWG | Class II | |
| K170780 | ARIX Foot System (2.3/2.8) | Jeil Medical Corporation | HRS | Class II | |
| K170321 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | 3M Company | JOJ | Class II | |
| K163398 | ATLANTIS suprastructures | Dentsply Sirona Inc | NHA | Class II | |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) | Polynovo Biomaterials Pty Ltd | QSZ | Unclassified | |
| K172122 | Sozo | Impedimed, Inc. | OBH | Class II | |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | MAX | Class II | |
| K171433 | Silk'n Infinity | Home Skinovations, Ltd. | OHT | Class II | |
| K170624 | TalarLift STS | Fusion Orthopedics, LLC | HWC | Class II | |
| K170574 | Diacap Pro Dialyzer | B. Braun Avitum AG | KDI | Class II | |
| K170492 | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics Inc | NTI | Class II | |
| K170037 | Breathe Technologies Life2000™ Ventilation System | Breathe Technologies, Inc. | CBK | Class II | |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | Signature Orthopaedics Pty Limited | KWQ | Class II | |
| K163367 | GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | PFX | Class II | |
| K163166 | EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only | Easywell Biomedicals, Inc. | NUH | Class II | |
| K162977 | ADVIA 2120i, ADVIA 2120 | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip | Cook Incorporated | BSR | Class I | |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd | NKB | Class II | |
| K172114 | Zimmer Natural Nail System | Zimmer GmbH | HSB | Class II | |
| K171565 | OEC Elite | GE Healthcare | OWB | Class II | |
| K171493 | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | QEX | Class II | |
| K171431 | HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm | Biostable Science & Engineering, Inc. | PST | Class II | |
| K171337 | LENSAR Laser System – fs 3D (LLS-fs 3D) | LENSAR, Inc | OOE | Class II | |
| K171200 | Grandio blocs | Voco GmbH | EBF | Class II | |
| K171116 | 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | 3M Healthcare | MSH | Class II | |
| K170488 | Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr | Surge Cardiovascular | DWF | Class II | |
| K163121 | SmartUs EXT-1M/3M | Telemed | IYN | Class II | |
| K172096 | Fraxis | Ilooda Co,., Ltd. | GEX | Class II | |
| K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit | Centers for Disease Control and Prevention | OZE | Class II | |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Alcon Laboratories | LPL | Class II | |
| K171809 | Epic Biliary Endoscopic Stent System | Boston Scientific Corporation | FGE | Class II | |
| K171071 | StimSox(TM) System | Stimmed, LLC | IPF | Class II | |
| K171070 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | GXI | Class II | |
| K170787 | Powered Wheelchair DYW30A(D09) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | ITI | Class II | |
| K170134 | Reperen Surgical Mesh | Iconlab, Inc. | FTL | Class II | |
| K170060 | M22 and ResurFx Systems | Lumenis Ltd | GEX | Class II | |
| K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | JWH | Class II |