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510(k) K140657

CUROS RED PORT PROTECTOR by Ivera Medical, Inc. — Product Code QBP

K140657 is an FDA 510(k) premarket notification submitted by Ivera Medical, Inc. for the device "CUROS RED PORT PROTECTOR". The FDA issued a decision of Substantially Equivalent on December 4, 2014. The device falls under product code QBP (Cap, Device Disinfectant), a Class II device regulated under 21 CFR 880.5440. Ivera Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2014
Date Received
March 14, 2014
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 by Ivera Medical, Inc.

  • K121171 — CUROS TIP (November 26, 2012)
  • K111992 — CUROS PORT PROTECTOR (January 12, 2012)
  • K110826 — CUROS PORT PROTECTOR (June 23, 2011)

Other clearances for product code QBP

  • K252006 — OTTO™ Disinfecting Cap (March 27, 2026)
  • 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)
  • K192382 — CapKlenZ (April 20, 2020)
  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K142806 — DualCap (May 22, 2015)
  • K142399 — DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (November 19, 2014)
  • K130975 — SWABCAP AND SWABFLUSH (December 24, 2013)

FDA data resources