# K982530: Sullivan Mirage Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Oct 16, 1998 after 88 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.
132 later devices descend from it; 7 cite it directly.
12 of 133 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™ Full Face Mask is a patient interface accessory for use with Constant Positive Airway Pressure (CPAP) and bilevel systems used in the treatment of adult Obstructive Sleep Apnea (OSA) and/or ventilatory support.

Source page: https://510kreport.com/device/K982530
Methodology: https://510kreport.com/methodology