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510(k) K192382

CapKlenZ by Star Mountain Medical, Inc. — Product Code QBP

K192382 is an FDA 510(k) premarket notification submitted by Star Mountain Medical, Inc. for the device "CapKlenZ". The FDA issued a decision of Substantially Equivalent on April 20, 2020. The device falls under product code QBP (Cap, Device Disinfectant), a Class II device regulated under 21 CFR 880.5440.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2020
Date Received
August 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Device Disinfectant
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time

Other clearances for product code QBP

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  • K251592 — SteriHub™ Disinfecting Device and Protective Cover (February 11, 2026)
  • K223914 — ACTIV™ Cap (April 5, 2024)
  • K193190 — BD PureHub Disinfecting Cap (November 9, 2020)
  • K200299 — Curos Jet Disinfecting Cap (October 29, 2020)
  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K142806 — DualCap (May 22, 2015)
  • K140657 — CUROS RED PORT PROTECTOR (December 4, 2014)
  • K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (November 19, 2014)
  • K130975 — SWABCAP AND SWABFLUSH (December 24, 2013)

FDA data resources