# K220591: Proxima

- Pathway: 510(k) (Traditional)
- Applicant: Dynasthetics, LLC
- Decided: Dec 15, 2022 after 289 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003455 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113111: Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion, Inovo, Inc. (2011) Summary page 4.

## Indications for use
The Proxima is intended for prescription use only, to be used for adult patients that require supplemental oxygen in a hospital setting.

Source page: https://510kreport.com/device/K220591
Methodology: https://510kreport.com/methodology