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

FDA 510(k) K211286 · Pall Corporation

Substantially Equivalent

510(k) numberK211286

Submission

Device name
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Applicant
Pall Corporation
Port Washington, NY, US
Received
April 27, 2021
Decision date
November 16, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAH – Filter, Bacterial, Breathing-Circuit
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5260
Specialty
Anesthesiology

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Questions and answers

When was Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger cleared by the FDA?

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (K211286) received a 510(k) decision of Substantially Equivalent on November 16, 2021, 203 days after the submission was received.

What is the product code of K211286?

The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.