510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211286Substantially Equivalent

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

Pall Corporation, Port Washington NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211286 is the FDA 510(k) clearance record for Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger, a class II device, cleared for Pall Corporation on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list one 510(k) clearance for Pall Corporation. As of , FDA records show no recalls naming K211286.

Clearance record

Decision date
Received
(203 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Pall Corporation 25 Harbor Park Dr., Port Washington NY
510(k) summary
Summary PDF
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