# K901831: Precision Medical Oxygen Regulator

- Pathway: 510(k) (Traditional)
- Applicant: Precision Medical, Inc.
- Decided: Aug 14, 1990 after 112 days
- Product code: CAN (Regulator, Pressure, Gas Cylinder)
- Device class: 1
- Regulation: 21 CFR 868.2700
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, 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

## Recalls of this device
- Oct 8, 2015 · Class II · Z-0272-2016: These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for

Source page: https://510kreport.com/device/K901831
Methodology: https://510kreport.com/methodology