510(k) · Cleared
ClearedIso-Gard Filter Straight; Humid-Vent Filter Compact Angled
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical Sdn. Bhd. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on May 15, 2026 as substantially equivalent to K965016 (Gibeck, Inc., 1997) and 1 other predicate after a 267-day review. Its family tree reaches back 1 generation to 1997. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- May 15, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964382 (1997). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK964382 Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact…Gibeck, Inc. · 1997
- This deviceK252643 Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026
Class I recalls in this family
- K965016 Iso-Gard Filter Angled (18212)/Iso-Gard Filter…direct predicate · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964382 | Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight… | Gibeck, Inc. | 1997 | — |
| 0 (this device) | K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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.
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? (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 |
|---|---|---|---|
| * | K965016 | Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212)Summary page 5…21 CFR 868.5260 Classification Name: Filter, Bacterial, Breathing-Circuit Classification II Classification Panel: Anesthesia E. Predicate Device K965016 Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212) K964382 Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filte… | 1997 |
| * | K964382 | Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402)Summary page 5…hing-Circuit Classification II Classification Panel: Anesthesia E. Predicate Device K965016 Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212) K964382 Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402) K252643 - Page 1 of 22 51… | 1997 |
| † | K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K965016Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212)Gibeck, Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 16 Class I recalls
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
Iso-Gard Filter Straight:
The device is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Humid-Vent Filter Compact Angled:
The device is a combined Heat and Moisture Exchanger (HME) and Bacterial/Viral Filter for humidification and bacterial/viral filtration during anesthesia and ventilator care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252643: Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252643
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026