510(k) · Cleared
ClearedMin-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Mar 1, 2005 as substantially equivalent to K030990 (Datex-Ohmeda, 2003) and 1 other predicate after a 109-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Mar 1, 2005
- Review
- 109 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K941381 (1994). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 4 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 3 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- 2 generations backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- 1 generation backK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- This deviceK043120 Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK072582 Provox Micron HmeAtos Medical AB · 2008
Most influential descendants
Showing 1 of 1 · See all- K072582Provox Micron HmeAtos Medical AB · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −4 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −3 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| −2 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| −1 | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| 0 (this device) | K043120 | Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter | Datex-Ohmeda, Inc. | 2005 | — |
| +1 | K072582 | Provox Micron Hme | Atos Medical AB | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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? (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 |
|---|---|---|---|
| * | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorSummary page 1…IAL EQUIVALENCE IS MADE as required by 807.92(a)(3) The Mini-Filter/S has the following similarities to the Datex-Ohmeda Mini-Filter/S predicate device (K030990). The Uni-Filter Junior, Uni-Filter/S, angled Uni-Filter/S and Uni-Filter are substantially equivalent in safety and effe… | 2003 |
| * | K990949 | Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas…Summary page 1…ngled Uni-Filter/S and Uni-Filter are substantially equivalent in safety and effectiveness to the legally marketed (predicate) Intersurgical Clear-Guard (K990949). Page 2 of 4… | 1999 |
| † | K023641 | Datex-Ohmeda Hmef Mini | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072582 | Provox Micron Hme | 2008 | 0 |
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 11 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K072582 (Atos Medical AB, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030990.
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?
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 Uni-Filter/S, angled Uni-Filter/S and Mini-Filter/S can also be used for gas sampling.
The device for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043120: Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043120
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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