510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190918Substantially Equivalent

SwabTip Male Disinfectant Cap

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

K190918 is the FDA 510(k) clearance record for SwabTip Male Disinfectant Cap, a class II device, cleared for Icu Medical 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 K190918.

Clearance record

Decision date
Received
(332 days to decision)
Product code
QBP Cap, Device Disinfectant
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical 600 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 October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260