# K211286: Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

- Pathway: 510(k) (Traditional)
- Applicant: Pall Corporation
- Decided: Nov 16, 2021 after 203 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092409 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092409: Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear Breathing Filter, Intersurgical, Inc. (2010) Summary page 4.

## Indications for use
The Pall® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moisture exchanger (HME) for patient side or machine side installation in breathing systems. It is designed to reduce bacterial/viral transmissions between the patient, the equipment and the environment and to reduce the loss of patient heat and humidity. The Ultipor® U55/U55N breathing circuit filter has >99.999% bacterial and >99.995% viral efficiency. The filter is for single patient use for adult patients, and is intended for use within breathing systems in healthcare and home environments where ventilation is required and for a maximum duration of 24 hours.

Source page: https://510kreport.com/device/K211286
Methodology: https://510kreport.com/methodology