# K952545: Wright 1000 Monoplace Hyperbaric System

- Pathway: 510(k) (Traditional)
- Applicant: Wright Industries
- Decided: May 28, 1997 after 726 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 K874107 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874107: H.T.U. (Hyperbaric Therapy Unit), Hyox Systems C/O Mechidyne Systems, Inc. (1987) Summary page 1.

## Indications for use
Hyperbaric oxygen therapy (HBO)is a medical treatment where a patient is placed in a specially designed vessel and placed under pressure greater then sea level and breathes 100% oxygen intermittently. Rlveolar oxygen pressure is increased causing a rise in plasma oxygen content which results in enhanced tissue oxygen delivery. the amount of pressure increases and the length of time under pressure are determined by the condition being treated. Treatment pressures are usually between 2 and 3 times atmospheric. treatment usually lasts from 1 to 2 hours at full pressure. The following are approved indications: Air or gas embolism. Carbon monoxide poisoning and smoke inhalation. Carbon monoxide complicated by cyanide poisoning. Clostridial myonecrosis (Gas gangrene). Crush injury, Compartment syndrome, and other acute traumatic ischemias. Decompression sickness. Enhancement of healing in selected problem wounds. Exceptional blood loss (Anemia) Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia). Osteomyelitis (Refractory). Radiation tissue damage (Osteoradionecrosis). Skin grafts and flaps (Compromised). Thermal burns. Adjunctive hyperbaric oxygen in intracranial abscess.

Source page: https://510kreport.com/device/K952545
Methodology: https://510kreport.com/methodology