# K172365: Panoramic Oxygen Mask (POM)

- Pathway: 510(k) (Traditional)
- Applicant: Pom Medical, LLC
- Decided: Apr 19, 2018 after 258 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 K971229 (1997). 2 ancestors in all.
2 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)
- K133806: M1 Capnography Mask, Monitor Mask, Inc. (2013) Summary page 4.

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

## Indications for use
The Panoramic Oxygen Mask (POM) is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.

Source page: https://510kreport.com/device/K172365
Methodology: https://510kreport.com/methodology