510(k) · Cleared
ClearedBacstop Filter,Bacstop Filter/Hme
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Munktell Filter AB · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Jun 26, 2002 as substantially equivalent to K881657 (Gibeck Respiration, 1988) and 3 other predicates after a 181-day review. Its family tree reaches back 1 generation to 1988. 2 of the 9 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jun 26, 2002
- Review
- 181 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K881657 (1988). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK881657 Humid-Vent FilterGibeck Respiration · 1988
- This deviceK014282 Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB · 2002
- Descendant · cites it directly · 3 of its ownK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK132709 VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014
- Descendant · 3 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 ownK090738 Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · cites it directly3descendants
- K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014 · 2 generations on1descendant
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 3 generations on0descendants
- K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881657 | Humid-Vent Filter | Gibeck Respiration | 1988 | — |
| 0 (this device) | K014282 | Bacstop Filter,Bacstop Filter/Hme | Munktell Filter AB | 2002 | — |
| +1 | K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 | Draeger Medical AG & Co. KG | 2008 | Class I |
| +2 | K132709 | VR Medical Heat and Moisture Exchanger and Filter | Vr Medical | 2014 | — |
| +3 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | Class I |
| +2 | K090738 | Thermoflo HCH, Thermoflo Filter | Arc Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 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.
2 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? (4)
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 |
|---|---|---|---|
| * | K881657 | Humid-Vent FilterSummary page 1…d Heat and Moisture Exchanger Classification Name: Filter, Bacterial, Breathing Circuit Predicate Devices: Gibeck - Humid-Vent Filter - K881657 Hudson RCI (Artema) Aqua +FH - K945359 Mallinckrodt - Hyg… | 1988 |
| * | K945359 | Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-HSummary page 1…Bacterial, Breathing Circuit Predicate Devices: Gibeck - Humid-Vent Filter - K881657 Hudson RCI (Artema) Aqua +FH - K945359 Mallinckrodt - Hygroboy and Hygrobac - K94 138 1 Mallinck… | 1995 |
| * | K941381 | Hygrobac,S Hygroboy and HygrobabySummary page 1…nt Filter - K881657 Hudson RCI (Artema) Aqua +FH - K945359 Mallinckrodt - Hygroboy and Hygrobac - K94 138 1 Mallinckrodt - Barrierbac and Barrierbac “S” - K941536 The Munktell Bacstop Filter and Fil… | 1994 |
| * | K941536 | Barrierbac and Barrierbac SSummary page 1…9 Mallinckrodt - Hygroboy and Hygrobac - K94 138 1 Mallinckrodt - Barrierbac and Barrierbac “S” - K941536 The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 min connectors w… | 1994 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 Class I | 2008 | 3 |
Has anything in its family been recalled? (2 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.
- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Cites it directly · ◆ 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
What does this lineage say?
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K072002 (Draeger Medical AG & Co. KG, 2008) has gone furthest, with 3 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?
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.
For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults).
Single patient use. Duration of use up to 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014282: Bacstop Filter,Bacstop Filter/Hme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014282
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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