510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080579Substantially Equivalent

Effectiv (Tm) Cap

Abbott Medical, Lake Forest IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080579 is the FDA 510(k) clearance record for EFFECTIV (TM) CAP, a class II device, cleared for Hospira, Inc. on under FDA product code QBP (Cap, Device Disinfectant). FDA's definition for product code QBP reads: "Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time". FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K080579.

Clearance record

Decision date
Received
(192 days to decision)
Product code
QBP Cap, Device Disinfectant
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Hospira, Inc. 275 N. Field Dr., Lake Forest IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBP

Trailing 12 months
2 clearances under product code QBP in the twelve months to November 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QBP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260