# K974417: Sullivan Vpap II ST-a Nasal Vpap System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Jun 24, 1998 after 212 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
70 later devices descend from it; 2 cite it directly.
10 of 71 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.

## Most influential descendants
- K033276: Vpap Iii ST-a (2004), 68 descendants of its own
- K060105: Vpap Iii ST-a/Kidsta Mask System (2006), 53 descendants of its own
- K051364: Vpap Adapt (2005), 36 descendants of its own
- K063533: Bipap Synchrony (2007), 30 descendants of its own
- K071509: Bipap Synchrony 2 Ventilatory Support System (2007), 28 descendants of its own

## Indications for use
The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.

Source page: https://510kreport.com/device/K974417
Methodology: https://510kreport.com/methodology