# K140473: Dualguard

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical, Ltd.
- Decided: Apr 10, 2014 after 44 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: 3 generations back to K896691 (1990). 9 ancestors in all.
1 later device descends 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)
- K080527: Twinguard with Capnograph Accessory, Trawax Pty Limited (2008) Summary page 1.

## Most influential descendants
- K240937: AIM (N/A) (2024), 0 descendants of its own

## Indications for use
DualGuardTM is intended for use in Adult patients who require supplemental oxygen delivery and C02 monitoring during endoscopy procedures and recovery. The complete device with bite block is to be used during endoscopy procedures. The DualGuardTM Bite Block is to be removed after endoscopy, leaving the 02 delivering/C02 sampling cannula in place for patient recovery period.

Source page: https://510kreport.com/device/K140473
Methodology: https://510kreport.com/methodology