# K983002: Mystique Ultrasonic Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Oct 16, 1998 after 49 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Airsep Mystique® ultrasonic nebulizer is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The Mystique® nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Source page: https://510kreport.com/device/K983002
Methodology: https://510kreport.com/methodology