510(k) · Cleared
ClearedDatex-Ohmeda Hmef 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Aug 30, 2002 as substantially equivalent to K964204 (Datex Engstrom AB, 1996) and 1 other predicate after a 130-day review. Its family tree reaches back 2 generations to 1994. 2 of the 20 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Aug 30, 2002
- Review
- 130 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941381 (1994). 8 ancestors in all. 11 later devices descend from it, 4 citing it directly. 2 of the 20 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 1 generation backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- This deviceK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- Descendant · cites it directly · 7 of its ownK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- Descendant · 2 generations on · 6 of its ownK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- Descendant · cites it directly · 4 of its ownK031653 Datex-Ohmeda Hmef 750Datex-Ohmeda · 2003
- Descendant · 2 generations on · 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
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K023641Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002 · cites it directly7descendants
- K030990Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003 · 2 generations on6descendants
- K031653Datex-Ohmeda Hmef 750Datex-Ohmeda · 2003 · cites it directly4descendants
- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · 2 generations on3descendants
- K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −1 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| 0 (this device) | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| +1 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| +2 | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| +1 | K031653 | Datex-Ohmeda Hmef 750 | Datex-Ohmeda | 2003 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K964204 | Engstrom Hmef 1000Summary page 1…07.92(a)(3) The Datex-Ohrneda HMEFSOO IS substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda HMEF1000 (K964204) and predicate EMS HEPA Filter and Hepa Fi1ter:HME (KO 13089).… | 1996 |
| * | K013089 | Ems Hepa Filter and Hme CombinationsSummary page 2…ients with lower tidal volumes. The HMEF 500 has a lower breathing resistance at 60 Ipm than the predicate EMS HEPA Filter and Hepa FilterMME (K013089). The HMEF 5 0 0 resistance at 60 Ipm is 3.3 cm H 2 0 compared to is 3.4 cm HzO for the predicate EMS HEPA Filter an… | 2002 |
What descends from it? (11)
See all 114 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 · 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
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K023641 (Datex-Ohmeda, 2002) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K964204.
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?
The HMEF500 is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF 500 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult and pediatric patients. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021265: Datex-Ohmeda Hmef 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021265
Report an extraction error
Are you the manufacturer?
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