510(k) · Cleared
ClearedEngstrom Hmef 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex Engstrom AB · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Nov 13, 1996 after a 76-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Nov 13, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK964204 Engstrom Hmef 1000Datex Engstrom AB · 1996
- Descendant · cites it directly · 11 of its ownK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- Descendant · 2 generations on · 7 of its ownK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- Descendant · 3 generations on · 6 of its ownK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- Descendant · 2 generations on · 4 of its ownK031653 Datex-Ohmeda Hmef 750Datex-Ohmeda · 2003
- Descendant · 3 generations on · 3 of its ownK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K021265Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002 · cites it directly11descendants
- K023641Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002 · 2 generations on7descendants
- K030990Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003 · 3 generations on6descendants
- K031653Datex-Ohmeda Hmef 750Datex-Ohmeda · 2003 · 2 generations on4descendants
- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964204 | Engstrom Hmef 1000 | Datex Engstrom AB | 1996 | — |
| +1 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| +2 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| +3 | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| +2 | K031653 | Datex-Ohmeda Hmef 750 | Datex-Ohmeda | 2003 | — |
| +3 | K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 | Draeger Medical AG & Co. KG | 2008 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 1 |
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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 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 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K021265 (Datex-Ohmeda, 2002) has gone furthest, with 11 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/K964204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964204: Engstrom Hmef 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964204
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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