Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger— 510(k) K211286

Name: FDA 510(k) clearance K211286
Creator: U.S. Food and Drug Administration
Published: 2021-11-16

Substantially Equivalent

Pall Corporation

FDA 510(k) clearance K211286 for Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger, Substantially Equivalent on 2021-11-16. Applicant: Pall Corporation. Device class: 2.

Clearance details

Applicant: Pall Corporation
Product code: Code CAH
Device class: Class 2
Regulation: 21 CFR 868.5260
Advisory panel: Anesthesiology
Date received: 2021-04-27
Decision date: 2021-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Washington, NY, US

Download summary PDF View on FDA.gov ↗

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K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)2023-09-16

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.