# K011866: Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Hyperbaric Technologies, Inc.
- Decided: Jun 6, 2002 after 357 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 K862198 (1986). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960389: Hyperbaric Chamber, Tampa Hyperbaric Ent. (1996) Summary page 2.
- K930748: Sigma MP Multiplace Hyperbaric Chamber, Perry Baromedical Services (1993) Summary page 2.
- K950957: Multiplace Hyperbaric Treatment Chamber System, Gulf Coast Hyperbarics, Inc. (1995) Summary page 2.
- K954387: T Class Hyperbaric Facilities, Reimers Systems, Inc. (1995) Summary page 3.

## Most influential descendants
- K152223: Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (2016), 1 descendant of its own
- K163109: OxyHeal 4000 Multiplace Hyperbaric Chamber Family (2017), 0 descendants of its own
- K052866: Oxyheal 1000 Monoplace Hyperbaric Chamber (2005), 0 descendants of its own

## Indications for use
It is the expressed, intended use of the OxyHeal2000 hyperbaric chamber series to provide therapy to those patients with selected medical conditions that have been determined to respond to the application of hyperbaric oxygen. As a Class I1 prescriptive device, it is further intended for physician involvement in its procurement and routine use.

Source page: https://510kreport.com/device/K011866
Methodology: https://510kreport.com/methodology