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510(k) K251592

SteriHub™ Disinfecting Device and Protective Cover by 1World Vista Medical — Product Code QBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2026
Date Received
May 23, 2025
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

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  • 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)
  • K123967 — CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (January 22, 2013)