# K961126: Pulse Dose Series

- Pathway: 510(k) (Traditional)
- Applicant: Devilbiss Health Care, Inc.
- Decided: Oct 21, 1996 after 214 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OMS 20: named in the summary without a submission number
- (no number) OMS 50: named in the summary without a submission number

## Most influential descendants
- K020329: Devilbiss PD1000 (2002), 5 descendants of its own
- K090421: Model 350G Gas Conserver (2009), 2 descendants of its own
- K033364: Chad Therapeutics Sage (2004), 2 descendants of its own
- K113111: Chad Therapeutic Evolution Electronic Oxygen Conserver with Motion (2011), 1 descendant of its own
- K220591: Proxima (2022), 0 descendants of its own

## Indications for use
The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liquid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.

Source page: https://510kreport.com/device/K961126
Methodology: https://510kreport.com/methodology