# K984428: Sullivan Autoset Nasal Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 26, 1999 after 234 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
No predicates in its family tree.
135 later devices descend from it; 6 cite it directly.
11 of 136 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
- K023244: Mirage Full Face Mask Series 2 (2002), 113 descendants of its own
- K023306: Mirage Full Face Mask Series 2 (2002), 96 descendants of its own
- K023284: Mirage Full Face Mask Series 2 (2002), 96 descendants of its own
- K032916: Mirage Activa Mask (2003), 93 descendants of its own
- K042403: Mirage Swift (2004), 80 descendants of its own

## Indications for use
The Sullivan Mirage Mask System is indicated for use with nasal Continuous Positive Airway Pressure (CPAP) and Variable Positive Airway Pressure (VPAP) systems for the indications specified in the relevant system’s labeling; and with other CPAP and bilevel systems recommended by a physician or respiratory therapist.

Source page: https://510kreport.com/device/K984428
Methodology: https://510kreport.com/methodology