# K133806: M1 Capnography Mask

- Pathway: 510(k) (Traditional)
- Applicant: Monitor Mask, Inc.
- Decided: Dec 31, 2013 after 15 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: 1 generation back to K971229 (1997). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K971229: Capnoxygen Mask, Medsys, Inc. (1997) Summary page 7.

## Most influential descendants
- K172365: Panoramic Oxygen Mask (POM) (2018), 2 descendants of its own
- K222511: Oxy2Pro (2023), 0 descendants of its own
- K220533: Endoscopy Oxygen Mask (2022), 0 descendants of its own

## Indications for use
The M1 Capnagraphy Mask is a single-use device intended for delivering supplemental oxygen and monitoring exhaled carbon dioxide in non-intubated spontaneously breathing patients. Standard oxygen tubing and two female luer ports for gas sample line attachment are included.

Source page: https://510kreport.com/device/K133806
Methodology: https://510kreport.com/methodology