# K052713: Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber

- Pathway: 510(k) (Special)
- Applicant: Sechrist Industries, Inc.
- Decided: Oct 28, 2005 after 29 days
- Product code: CBF (Chamber, Hyperbaric)
- Device class: 2
- Regulation: 21 CFR 868.5470
- Recalls of this device: 2 (0 Class I)
- 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 2.

## Most influential descendants
- K072427: Sigma Series Hyperbaric Chamber (2008), 0 descendants of its own

## Recalls of this device
- Aug 28, 2008 · Class II · Z-0208-2013: Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
- Aug 28, 2008 · Class II · Z-0209-2013: Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.

## Indications for use
The intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. Specific indications for use of 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 these recommendations. The thirteen 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 Ischemias 5. Decompression Sickness 6. Enhancement of Healing in Selected Problem Wounds 7. Exceptional 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 Burns

Source page: https://510kreport.com/device/K052713
Methodology: https://510kreport.com/methodology