510(k) · Cleared
ClearedDatex-Ohmeda Mini-Filter/S and Uni-Filter Junior
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 Jun 25, 2003 as substantially equivalent to K023641 (Datex-Ohmeda, 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1994. 2 of the 18 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Jun 25, 2003
- Review
- 89 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941381 (1994). 11 ancestors in all. 6 later devices descend from it, 2 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 3 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 2 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- 1 generation backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- This deviceK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- 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 · cites it directly · 1 of its ownK043120 Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc. · 2005
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · 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
- K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc. · 2005 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −4 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −3 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −2 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| −1 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| 0 (this device) | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| +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 | — |
| +1 | K043120 | Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter | Datex-Ohmeda, Inc. | 2005 | — |
| +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 | 3 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | K023641 | Datex-Ohmeda Hmef MiniSummary page 2…sture output and Breathing resistance The main differences between the Datex-Ohmeda Mini-Filter/S and the predicate Datex- Ohmeda HMEF Mini (K023641) are due to fact that Mini-Filter/s is intended use only as breathing system bacterial and viral filter and HMEF Mi… | 2002 |
| * | K941536 | Barrierbac and Barrierbac SSummary page 1…Datex-Ohrneda Uni- Filter Junior is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Mallinckrodt Barrierbac /S (K94 1536). Page 2 o f 4… | 1994 |
What descends from it? (6)
2 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 · 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 3 of the 11 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.
- 1 other device also cites its predicate K023641.
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?
Datex-Ohmeda Filters can be used to provide filtration for reducing possible cross contamination between patient and equipment. Filters are for use in the hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators for filtering particles including bacteria, viruses and dust from C02-absorbers.
The Mini-Filter/S can also be used for gas sampling.
The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030990: Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030990
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