# K962766: Airsep Impulse

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Oct 10, 1996 after 86 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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.
- (no number) Chad Therapeutics Oxymatic Electronic Oxygen Conserver Model 301: named in the summary without a submission number

## Most influential descendants
- K983459: Pulsed Oxygen Conserving Device, Pocd (1998), 3 descendants of its own
- K023420: Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, Reacteb (2002), 2 descendants of its own
- K033197: Inogen Satellite Conserver (2004), 1 descendant of its own
- K052563: Inogen Satellite Conserver, Model SC-100 (2005), 0 descendants of its own

## Indications for use
The AirSep Impulse Oxygen Conserving Device is to be normally used in a home or institutional environment for persons who suffer from various forms of Chronic Obstructive Pulmonary Disease (COPD). It is to be used only when a nasal oxygen cannula is prescribed. The Impulse has been designed to work in conjunction with a portable, regulated flow bottled oxygen source. The unit can be used with any oxygen source capable of delivering gaseous oxygen at 20 to 25 psig. Oxygen is delivered in a precise amount at the optimum point in the breathing cycle through the nasal cannula. This form of delivery maximizes the beneficial effects of supplemental oxygen while eliminating unnecessary waste, thus increasing user mobility and ambulatory duration of the user.

Source page: https://510kreport.com/device/K962766
Methodology: https://510kreport.com/methodology