# K102831: RSI 4200

- Pathway: 510(k) (Abbreviated)
- Applicant: Reimers Systems, Inc.
- Decided: Aug 19, 2011 after 324 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 K934164 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934164: Model 2500E/2500ER Hyperbaric Chamber, Sechrist Industries, Inc. (1995) Summary page 1.
- K041007: Millenium, Models 2000, 2001 and 2002, Hyperbaric For Life, LLC (2004) Summary page 1.

## Indications for use
Specific indications for use of hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific indications are: 1. Air or Gas Embolism 2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning 3. Clostridial Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Isehemnias 5. Decompression Sickness 6. Enhancement of Healing in Selected Problem Wounds 7. Exception Blood Loss (Anemia) 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 10. Osteomyelitis (Refractory) 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Skin Grafts and Flaps (Compromised) 13. Thermal Bums

Source page: https://510kreport.com/device/K102831
Methodology: https://510kreport.com/methodology