# K960593: Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry Airway, Model Number SA-100

- Pathway: 510(k) (Traditional)
- Applicant: Aradigm Corp.
- Decided: May 10, 1996 after 88 days
- Product code: CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer))
- Device class: 1
- Regulation: 21 CFR 868.5640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K872037 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940835: Peaklog and Display Software, Medtrac Technologies Corp. (1994) Summary page 1.
- K893665: Aerosol Inhalation Monitor, Vitalograph, Ltd. (1989) Summary page 1.
- K872037: Aerochamber, Monaghan Medical Corp. (1987) Summary page 1.

## Most influential descendants
- K051284: MD Turbo (2005), 0 descendants of its own

## Indications for use
The Aradigm Corporation SmartMist™ Asthma Management System is intended for use by asthma patients who self medicate with metered dose inhalers (MDI) and who measure peak expiratory flow rate (PEFR) as part of their asthma management programs.

Source page: https://510kreport.com/device/K960593
Methodology: https://510kreport.com/methodology