510(k) · Cleared
ClearedPortex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Ltd. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Nov 28, 2003 as substantially equivalent to K791307 (Pall Biomedical Products Co., 1979) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Nov 28, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791307 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK791307 Unipor Breathing Circuit FilterPall Biomedical Products Co. · 1979 · Recalled
- This deviceK032716 Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile…Portex, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791307 | Unipor Breathing Circuit Filter | Pall Biomedical Products Co. | 1979 | 1 |
| 0 (this device) | K032716 | Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and… | Portex, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K791307 | Unipor Breathing Circuit FilterSummary page 1…5260 PREDICATE DEVICES: Pall BB25 Small Volume HME filter with monitoring port, already marketed in the USA under Pre- market Notification No.K791307 (Trade name - Pall Ultipor 25 breathing system filter) Porous Media Corporation DBF23 Bacterial/Viral filter already m… | 1979 |
| * | K964979 | Porous Media DBF23 Disposable Respiratory FilterSummary page 1…tipor 25 breathing system filter) Porous Media Corporation DBF23 Bacterial/Viral filter already marketed in the USA under Pre-market Notification No.K964979 DEVICE DESCRIPTION: The Thermovent HEPA (High Efficiency Particulate Air) HME (Heat and Moisture Exchange) breathing… | 1997 |
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?
- 1 of the 2 ancestors has a recall of any class.
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 Portex Thermovent HEPA (High Efficiency Particulate) is a single use heat and moisture exchanging (HME) bacterial/viral breathing system filter with 'HEPA' grade filtration properties.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032716: Portex Thermovent Hepa Hme Breathing Filter with CO2 Port (Sterile and Non-Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032716
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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