# K964541: Sanpo I

- Pathway: 510(k) (Traditional)
- Applicant: Koike Medical Co.
- Decided: Sep 26, 1997 after 329 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K833994 (1983). 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)
- K833994: Pulsair I & II, Cryo Corp. (1983) Summary page 1.

## Indications for use
For use by adults in conjunction with portable oxygen supply units to conserve and regulate oxygen supply and consumption. SANPO is not intended for use by neo-natal or pediatric patients.

Source page: https://510kreport.com/device/K964541
Methodology: https://510kreport.com/methodology