510(k) · Cleared
ClearedSunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunset Healthcare Solutions, LLC · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Sep 13, 2011 as substantially equivalent to K021265 (Datex-Ohmeda, 2002) after a 379-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 13, 2011
- Review
- 379 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K941381 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 2 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 1 generation backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- This deviceK102483 Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104Sunset Healthcare Solutions, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −2 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −1 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| 0 (this device) | K102483 | Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104 | Sunset Healthcare Solutions, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 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? (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 |
|---|---|---|---|
| * | K021265 | Datex-Ohmeda Hmef 500Summary page 2…he BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy. Legally Marketed Device to Which Substantial Equivalence is Claimed DATEX-OHMEDA HMEF 500 (K021265) Device Description The BHF 104 filter is a single-use, barrier type filter, fabricated from a plastic resin, and delivered to… | 2002 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K021265.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The BHF 104 is a disposable single-use filter for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross-contamination between patient and equipment. The BHF 104 is for use in hospital, ICU, anesthesia, and respiratory therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102483: Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102483
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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