510(k) · Cleared
ClearedHumid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gibeck, Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Apr 15, 1997 after a 162-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 15, 1997
- Review
- 162 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK964382 Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact…Gibeck, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK163300 ThermoShield HME FilterFlexicare Medical Limited. · 2017
- Descendant · cites it directly · 0 of its ownK252643 Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026
- Descendant · 2 generations on · 0 of its ownK241339 Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
- Descendant · 2 generations on · 0 of its ownK210352 GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK091185 70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral FilterHsiner Co., Ltd. · 2009
Most influential descendants
Showing 5 of 5 · See all- K163300ThermoShield HME FilterFlexicare Medical Limited. · 2017 · cites it directly2descendants
- K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026 · cites it directly0descendants
- K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024 · 2 generations on0descendants
- K210352GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022 · 2 generations on0descendants
- K09118570530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral FilterHsiner Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964382 | Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight… | Gibeck, Inc. | 1997 | — |
| +1 | K163300 | ThermoShield HME Filter | Flexicare Medical Limited. | 2017 | — |
| +1 | K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026 | — |
| +2 | K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | 2024 | — |
| +2 | K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022 | — |
| +1 | K091185 | 70530-Bactial/Viral Filter, 70531-Hmef, 70536-Bacterial/Viral Filter | Hsiner Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Gibeck Humid-Vent Filter heat and moisture exchanger Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K163300 (Flexicare Medical Limited., 2017) has gone furthest, with 2 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/K964382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964382
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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