# K983736: Icel Evolusonic Portable Ultrasonic Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Brasamerica Medical Equipment, Inc.
- Decided: Nov 10, 1998 after 19 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
Longest line of descent: 1 generation back to K972371 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972371: Icel Ultrasonic Nebulizer Models PU 12000 Air and PU 12300 Air, Brasamerica Medical Equipment, Inc. (1997) Summary page 1.

## Indications for use
This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing for use by both the adult and pediatric populations.

Source page: https://510kreport.com/device/K983736
Methodology: https://510kreport.com/methodology