# K220533: Endoscopy Oxygen Mask

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems, Inc.
- Decided: Nov 16, 2022 after 265 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 K971229 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172365: Panoramic Oxygen Mask (POM), Pom Medical, LLC (2018) Summary page 4.

## Indications for use
The Endoscopy Oxygen Mask 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/K220533
Methodology: https://510kreport.com/methodology