# K100268: Sechrist Monoplace Hyperbaric Oxygen Chamber

- Pathway: 510(k) (Special)
- Applicant: Sechrist Industries, Inc.
- Decided: Apr 26, 2010 after 87 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 K950386 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950386: Model 3200P/3200PR Hyperbaric Chamber, Sechrist Industries, Inc. (1995) Summary page 1.

## Most influential descendants
- K140559: Sechrist Monoplace Hyperbaric Oxygen Chamber (2014), 0 descendants of its own

## Indications for use
The intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigators in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery, trauma surgery, thoracic surgery, otolaryngology, oral and maxillofacial surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vivo or in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursement and most insurance carriers have established reimbursement policy based on the recommendations. The thirteen indications are: 1. Air or Gas embolism 2. Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3.3 Clostridial Myonecrosis and Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias 5. Decompression Sickness 6. Arterial Insufficiencies Central Retinal Artery Occlusion Enhancement of Heating In Selected Problem Wounds 7. Severe Anemia 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections 10. Osteomyelitis (Refractory) 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis) 12. Compromise Grafts and Flaps 13. Thermal Bums

Source page: https://510kreport.com/device/K100268
Methodology: https://510kreport.com/methodology