510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K110246Substantially Equivalent

Medisize Red and Medisize Blue

Qserve America, Inc., Claremont NH / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K110246 is the FDA 510(k) clearance record for MEDISIZE RED AND MEDISIZE BLUE, a class II device, cleared for Qserve America, Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 2 510(k) clearances for Qserve America, Inc., from to . As of , FDA records show no recalls naming K110246.

Clearance record

Decision date
Received
(281 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Qserve America, Inc. 220 River Rd., Claremont NH
510(k) summary
Statement
Third party review
No

Clearances, product code CAH

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