510(k) · Cleared
Recalled · Class I · 2022Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212)
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 Dec 2, 1997 after a 351-day review. The FDA summary names its predicate without a number. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 6 times, including 6 Class I recalls.
- Decided
- Dec 2, 1997
- Review
- 351 days
- Class
- Class II
- Product code
- CAH
- Recalls
- 6 (6 Class I)
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK965016 Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212)Gibeck, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK252643 Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965016 | Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212) | Gibeck, Inc. | 1997 | — |
| +1 | K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | — | Dryden Mini Bacteria Filter Named without a submission number |
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 |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2022 | Class I | Z-0072-2023 | Under Investigation by firm | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | Class I | Z-0076-2023 | Under Investigation by firm | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | Class I | Z-0075-2023 | Under Investigation by firm | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | Class I | Z-0073-2023 | Under Investigation by firm | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | Class I | Z-0077-2023 | Under Investigation by firm | Incidents of device splitting or detaching during use |
| Aug 29, 2022 | Class I | Z-0074-2023 | Under Investigation by firm | Incidents of device splitting or detaching during use |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K252643 (Teleflex Medical Sdn. Bhd., 2026) has gone furthest, with 0 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 | — |
What is it indicated for?
Intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965016 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965016: Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965016
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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