510(k) · Cleared
Recalled · Class II · 2021Sterivent and Sterivent S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Medical · CAH Filter, Bacterial, Breathing-Circuit
Cleared on May 20, 1994 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 of the 42 devices in its family, counting itself, have a Class I recall. 41 later devices descend from it. It has been recalled once.
- Decided
- May 20, 1994
- Review
- 45 days
- Class
- Class II
- Product code
- CAH
- Recalls
- 1
- Predicates
- 0
41 later devices descend from it, 2 citing it directly. 8 of the 42 devices in this family, counting this one, have a Class I recall.
- This deviceK941676 Sterivent and Sterivent SMallinckrodt Medical · 1994
- Descendant · cites it directly · 39 of its ownK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- Descendant · 2 generations on · 29 of its ownK033008 Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd. · 2004
- Descendant · 3 generations on · 22 of its ownK060705 Carina HomeDraeger Medical B.V. · 2006 · Recalled
- Descendant · 4 generations on · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 2 generations on · 11 of its ownK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 41 · See all- K013089Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002 · cites it directly39descendants
- K033008Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd. · 2004 · 2 generations on29descendants
- K060705Carina HomeDraeger Medical B.V. · 2006 · 3 generations on22descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · 4 generations on20descendants
- K021265Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941676 | Sterivent and Sterivent S | Mallinckrodt Medical | 1994 | — |
| +1 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| +2 | K033008 | Air Safety Hepa and Non-Hepa Filters | Air Safety, Ltd. | 2004 | — |
| +3 | K060705 | Carina Home | Draeger Medical B.V. | 2006 | 1 |
| +4 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +2 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 2 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 2 |
| 2013 | 2 | 1 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
8 devices in this family have 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (41)
See all 412 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2021 | Class II | Z-1866-2021 | Material/Component Contamination | The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization. |
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.
- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- Of its descendants, K013089 (Engineered Medical Systems, 2002) has gone furthest, with 39 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 | — |
https://510kreport.com/device/K941676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941676: Sterivent and Sterivent S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941676
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026