# K914978: Oxyguard

- Pathway: 510(k) (Traditional)
- Applicant: Stantex Pty, Ltd.
- Decided: Jan 10, 1992 after 65 days
- Product code: MNK (Endoscopic Bite Block)
- Device class: 1
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042665: Smart Bitebloc (2004), 3 descendants of its own
- K080527: Twinguard with Capnograph Accessory (2008), 2 descendants of its own
- K140473: Dualguard (2014), 1 descendant of its own
- K240937: AIM (N/A) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K914978
Methodology: https://510kreport.com/methodology