510(k) · Cleared
ClearedPall Ultipor Anesthesia Breathing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pall Medical · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Aug 1, 2002 after a 318-day review. The FDA summary names its predicate without a number. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Aug 1, 2002
- Review
- 318 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK013093 Pall Ultipor Anesthesia Breathing SystemPall Medical · 2002
- Descendant · cites it directly · 2 of its ownK191909 HepaShield Bacterial Viral Breathing System FilterFlexicare Medical Limited. · 2020
- Descendant · 2 generations on · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK210352 GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022
Class I recalls in this family
- K221836 Filter CareStar Plus, Filter SafeStar Plus…2 generations on · 2022
Most influential descendants
Showing 3 of 3 · See all- K191909HepaShield Bacterial Viral Breathing System FilterFlexicare Medical Limited. · 2020 · cites it directly2descendants
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 2 generations on0descendants
- K210352GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013093 | Pall Ultipor Anesthesia Breathing System | Pall Medical | 2002 | — |
| +1 | K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | 2020 | — |
| +2 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | Class I |
| +2 | K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Zefon Anesthesia Breathing System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191909 | HepaShield Bacterial Viral Breathing System Filter | 2020 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K191909 (Flexicare Medical Limited., 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Anesthesia Breathing Circuit System with a Breathing System Filter (“BSF’) is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013093: Pall Ultipor Anesthesia Breathing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013093
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026