# K972371: Icel Ultrasonic Nebulizer Models PU 12000 Air and PU 12300 Air

- Pathway: 510(k) (Traditional)
- Applicant: Brasamerica Medical Equipment, Inc.
- Decided: Aug 19, 1997 after 55 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983736: Icel Evolusonic Portable Ultrasonic Nebulizer (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K972371
Methodology: https://510kreport.com/methodology