# K101262: Flexi-Lite

- Pathway: 510(k) (Traditional)
- Applicant: Pressure-Tech, Inc.
- Decided: Jun 10, 2010 after 36 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: 2 generations back to K874752 (1988). 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)
- K051759: Flexi-Lite, Model FL-V1.2, Performance Hyperbarics (2005) Summary page 1.

## Indications for use
The Flexi-Lite Hyperbaric chamber is a hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician. Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K101262
Methodology: https://510kreport.com/methodology