# K965016: Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212)

- Pathway: 510(k) (Traditional)
- Applicant: Gibeck, Inc.
- Decided: Dec 2, 1997 after 351 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 6 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dryden Mini Bacteria Filter: named in the summary without a submission number

## Most influential descendants
- K252643: Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (2026), 0 descendants of its own

## Recalls of this device
- Aug 29, 2022 · Class I · Z-0072-2023: Incidents of device splitting or detaching during use
- Aug 29, 2022 · Class I · Z-0076-2023: Incidents of device splitting or detaching during use
- Aug 29, 2022 · Class I · Z-0075-2023: Incidents of device splitting or detaching during use
- Aug 29, 2022 · Class I · Z-0073-2023: Incidents of device splitting or detaching during use
- Aug 29, 2022 · Class I · Z-0077-2023: Incidents of device splitting or detaching during use
- Aug 29, 2022 · Class I · Z-0074-2023: Incidents of device splitting or detaching during use

## Indications for use
Intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Source page: https://510kreport.com/device/K965016
Methodology: https://510kreport.com/methodology