510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130975Substantially Equivalent

Swabcap and Swabflush

Excelsior Medical LLC, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130975 is the FDA 510(k) clearance record for SWABCAP AND SWABFLUSH, a class II device, cleared for Excelsior Medical Corp. 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 11 510(k) clearances for Excelsior Medical Corp., from to . As of , FDA records show 2 recalls naming K130975.

Clearance record

Decision date
Received
(260 days to decision)
Product code
QBP Cap, Device Disinfectant
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Excelsior Medical Corp. 555 13th St., NW, Washington DC
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