# K080527: Twinguard with Capnograph Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Trawax Pty Limited
- Decided: Oct 31, 2008 after 248 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896691 (1990). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914978: Oxyguard, Stantex Pty, Ltd. (1992) Summary page 1.
- K011125: Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci, Hudson Respiratory Care, Inc. (2001)
- K042665: Smart Bitebloc, Oridion Medical 1987, Ltd. (2004) Summary page 1.

## Most influential descendants
- K140473: Dualguard (2014), 1 descendant of its own
- K240937: AIM (N/A) (2024), 0 descendants of its own

## Indications for use
TwinGuard ®, a nasal oxygen cannula and bite block, is used during endoscopy procedures to administer continuous oxygen to the nose and mouth. After endoscopy the bite block is removed, leaving the cannula in place during recovery, to continue delivering oxygen to the nose and mouth. In addition, the TwinGuard ® contains an optional accessory which collects samples of the patient's breathing at the nose and mouth to measure CO 2 with a capnograph during endoscopy procedures. It is intended for adult patients.

Source page: https://510kreport.com/device/K080527
Methodology: https://510kreport.com/methodology