# K950777: Oxygen Regulator

- Pathway: 510(k) (Traditional)
- Applicant: Mada Medical Products, Inc.
- Decided: Apr 14, 1995 after 52 days
- Product code: CAN (Regulator, Pressure, Gas Cylinder)
- Device class: 1
- Regulation: 21 CFR 868.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K061785: Cyl-Fil Oxygen System (2006), 1 descendant of its own
- K080243: Portable Oxygen Unit SCA900 (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K950777
Methodology: https://510kreport.com/methodology