# K971229: Capnoxygen Mask

- Pathway: 510(k) (Traditional)
- Applicant: Medsys, Inc.
- Decided: Sep 23, 1997 after 174 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have 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) Jemsdal A-221 Capnographic Mask: named in the summary without a submission number

## Most influential descendants
- K133806: M1 Capnography Mask (2013), 3 descendants of its own
- 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
- K131339: Capnomask (2013), 0 descendants of its own

## Indications for use
The CAPNOXYGEN mask is a medium concentration single-use mask intended to be used for the delivery of supplemental oxygen and monitoring breathing by sampling exhaled carbon dioxide. Standard connectors for the oxygen tubing and a standard female Luer connector for the gas sample line are provided. The mask is intended to be used for monitoring non-intubated patients who are breathing spontaneously.

Source page: https://510kreport.com/device/K971229
Methodology: https://510kreport.com/methodology