510(k) · Cleared
ClearedUltipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pall Corporation · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Nov 16, 2021 as substantially equivalent to K092409 (Intersurgical, Inc., 2010) after a 203-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Nov 16, 2021
- Review
- 203 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092409 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK092409 Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger…Intersurgical, Inc. · 2010
- This deviceK211286 Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture…Pall Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092409 | Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and… | Intersurgical, Inc. | 2010 | — |
| 0 (this device) | K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092409 | Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear…Summary page 4…ate Device: Intersurgical, Inc. Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger (Model 1745) (K092409) Intended Use/Indications for Use The Pall® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moistu… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211286: Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211286
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026