# K220290: Revitalair 430+

- Pathway: 510(k) (Traditional)
- Applicant: Us Hyperbaric Network
- Decided: May 4, 2023 after 457 days
- Product code: CBF (Chamber, Hyperbaric)
- Device class: 2
- Regulation: 21 CFR 868.5470
- 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 K011312 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171899: Revitalair 430F, Oxavita Srl (2019) Summary page 4.

## Indications for use
The intended use of the Portable Hyperbaric Chamber Revitalair® 430+ is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at health institutions and physician offices.

Source page: https://510kreport.com/device/K220290
Methodology: https://510kreport.com/methodology