# K974539: Sullivan Vpap II ST Ventilatory Support System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Aug 6, 1998 after 246 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- 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.
26 later devices descend from it; 1 cites it directly.
5 of 27 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
- K053607: Breas Vivo 40 System (2006), 25 descendants of its own
- K071702: Breas Vivo Bilevel System, Model Vivo 40 (2008), 24 descendants of its own
- K090113: Breas Vivo 40 System (2009), 23 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

## Indications for use
The SULLIVAN® VPAP™ II ST Ventilatory Support System is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.

Source page: https://510kreport.com/device/K974539
Methodology: https://510kreport.com/methodology