510(k) · Cleared
ClearedHepaShield Bacterial Viral Breathing System Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicare Medical Limited. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Mar 23, 2020 as substantially equivalent to K013093 (Pall Medical, 2002) after a 250-day review. Its family tree reaches back 1 generation to 2002. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 23, 2020
- Review
- 250 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013093 (2002). 2 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK013093 Pall Ultipor Anesthesia Breathing SystemPall Medical · 2002
- This deviceK191909 HepaShield Bacterial Viral Breathing System FilterFlexicare Medical Limited. · 2020
- Descendant · cites it directly · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)
- Descendant · cites it directly · 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…cites it directly · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013093 | Pall Ultipor Anesthesia Breathing System | Pall Medical | 2002 | — |
| 0 (this device) | K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | 2020 | — |
| +1 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | Class I |
| +1 | K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013093 | Pall Ultipor Anesthesia Breathing SystemSummary page 4…acterial filter: 21 CFR 868.5260 Product Codes: CAH (Breathing circuit bacterial filter) Predicate Device: Pall’s Ultipor 25 Bacterial Viral Breathing System Filter (K013093) Device Description: Flexicare’s HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K221836 (Drägerwerk AG & Co. KGaA, 2022) has gone furthest, with 0 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. 2020, 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?
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult size. Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191909: HepaShield Bacterial Viral Breathing System Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191909
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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