# K051988: Oxy-Serve II Oxygen Conserving Regulator

- Pathway: 510(k) (Traditional)
- Applicant: Superior Products, Inc.
- Decided: Sep 21, 2005 after 61 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010747 (2001). 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)
- K010747: Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830, Western Ent. (2001) Summary page 1.

## Recalls of this device
- Oct 19, 2007 · Not classified · Z-0529-2008: Leakage: Device was leaking oxygen

## Indications for use
The Oxy-Serve Ii Oxygen Conserving Regulator is intended as an oxygen conservinga pressure regulator for ambulatory patients. The Conserving Regulator delivers the prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.

Source page: https://510kreport.com/device/K051988
Methodology: https://510kreport.com/methodology