# K990856: Heritage Nasal Cpap System, Model P/N 15682

- Pathway: 510(k) (Traditional)
- Applicant: Bird Products Corp.
- Decided: Jan 11, 2000 after 302 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- 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 K930656 (1994). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930656: Sullivan Iii Nasal Cpap System, Rescare, Ltd. (1994) Summary page 4.

## Most influential descendants
- K020730: Orion Nasal Cpap System (2002), 1 descendant of its own
- K022192: Pegasus Nasal Cpap System (2003), 0 descendants of its own

## Indications for use
The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the airway to stay open. The nasal CPAP unit is intended only for spontaneously breathing adult patients.

Source page: https://510kreport.com/device/K990856
Methodology: https://510kreport.com/methodology