# K020974: Bara-Med Acrylic Monoplace Hyperbaric Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Environmental Tectonics Corp.
- Decided: Jun 26, 2002 after 92 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). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.
- (no number) Dixie Manufacturing Co.’s Dixie 800-45: named in the summary without a submission number
- (no number) Perry Baromedical’s Sigma 1: named in the summary without a submission number
- (no number) Sechrist Industry’s Sechrist 2500: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K950356: Sechrist Industry’s Sechrist 3200. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K072427: Sigma Series Hyperbaric Chamber (2008), 0 descendants of its own
- K052866: Oxyheal 1000 Monoplace Hyperbaric Chamber (2005), 0 descendants of its own

## Indications for use
The BARA-MED Monoplace Hyperbaric Chamber is a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA (Atmospheres Absolute).

Source page: https://510kreport.com/device/K020974
Methodology: https://510kreport.com/methodology