# K861593: Topical Hyperbaric Oxygen Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Stephenson Industries, Inc.
- Decided: May 12, 1986 after 13 days
- Product code: KPJ (Chamber, Oxygen, Topical, Extremity)
- Device class: 2
- Regulation: 21 CFR 878.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971507: O2 BOOT (1997), 10 descendants of its own
- K023456: Oxybox System (2003), 4 descendants of its own
- K022028: VX-400 Topical Hyperbaric Oxygen Chamber (2002), 4 descendants of its own
- K080966: Hyper-Box Topical Wound Oxygen System (2008), 2 descendants of its own
- K212121: VHT-200 Wound Treatment System (2023), 1 descendant of its own

Source page: https://510kreport.com/device/K861593
Methodology: https://510kreport.com/methodology