# K072757: Dive and Shallow and Grand Dive

- Pathway: 510(k) (Traditional)
- Applicant: Summit TO Sea
- Decided: Feb 8, 2008 after 134 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 K011312 (2001). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874752: Gamow Hyperbaric Bag, Hyperbaric Aerobics, Ltd. (1988) Summary page 1.
- K001409: Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-Cizer, Hyperbaric Technologies, Inc. (2000) Summary page 3.
- K060739: Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307, Khrunichev State Research & Production Space Centr (2006) Summary page 1.

## Most influential descendants
- K171899: Revitalair 430F (2019), 1 descendant of its own
- K220290: Revitalair 430+ (2023), 0 descendants of its own

## Indications for use
The Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat: Acute Mountain sickness (AMS) as prescribed by or under the direction of a physician.

Source page: https://510kreport.com/device/K072757
Methodology: https://510kreport.com/methodology