# K970371: Flotec Oxysavrr (S)

- Pathway: 510(k) (Traditional)
- Applicant: Flotec, Inc.
- Decided: Jul 10, 1997 after 160 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF. THE DEVICE IS AN OPTIONAL COMPONENT OF THE OXYGEN DELIVERY SYSTEM PRESCRIBED FOR USE BY PATIENTS SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THE SOLE PURPOSE OF THIS DEVICE IS TO CONSERVE OXYGEN BY STOPPING THE FLOW WHEN THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND INHALING. FLOW RESUMES WHEN THE DEVICE SENSES THE BEGINNING OF INHALATION BY THE USER.

Source page: https://510kreport.com/device/K970371
Methodology: https://510kreport.com/methodology