# K241366: QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

- Pathway: 510(k) (Traditional)
- Applicant: Dehas Medical Systems GmbH
- Decided: Oct 29, 2024 after 168 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- 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 K953349 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953349: Spiracle Technoloty Gaseous Oxygen Supply Valve, Spiracle Technology (1996) Summary page 6.

## Indications for use
The demand valve is used for the application of 100 vol% oxygen during manual ventilation with the resuscitator bag, as well as during direct non-invasive inhalation with the resuscitator mask in spontaneously breathing patients. CAUTION: Federal law restricts this device to sale by or on the order of a physician

Source page: https://510kreport.com/device/K241366
Methodology: https://510kreport.com/methodology