Cleared Traditional

CapKlenZ

K192382 · Star Mountain Medical, Inc. · General Hospital
Apr 2020
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K192382 is an FDA 510(k) clearance for the CapKlenZ, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Star Mountain Medical, Inc. (El Paso, US). The FDA issued a Cleared decision on April 20, 2020, 234 days after receiving the submission on August 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K192382 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2019
Decision Date April 20, 2020
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QBP — Cap, Device Disinfectant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440
Definition Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time