# K021689: Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2

- Pathway: 510(k) (Abbreviated)
- Applicant: Pan-America Hyperbarics, Inc.
- Decided: Oct 24, 2002 after 154 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: 1 generation back to K930748 (1993). 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)
- K001121: Oxygen Applied Symptom Improvement System (Oasis), Engineered Medical Technology, Inc. (2001)
- K930748: Sigma MP Multiplace Hyperbaric Chamber, Perry Baromedical Services (1993) Summary page 1.
- K950957: Multiplace Hyperbaric Treatment Chamber System, Gulf Coast Hyperbarics, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K095438: Reimers T Class Hyperbaric Facility. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The conditions listed as appropriate for the use of HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1 999) are as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cjanide poisoning 3. Clostridial myositis and inyonecrosis 4. Crush injury, compartment syndrome. and other acute traumatic iscliemias 5. Decompression sickness 6. Enhanced healing of selected problem wounds 7. Exceptional blood loss anemia 8. Necrotizing soft tissue infections 9. Osteomyelitis (refractorq.) 10. Delajred radiation injury (soft tissue and bony necrosis) 11. Skin grafts and flaps (compromised) 12. Thernial burns 13. Intracranial abscess

Source page: https://510kreport.com/device/K021689
Methodology: https://510kreport.com/methodology