# K980024: Shinmed Model SW-966 Ultrasonic Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Shining World Health Care Co., Ltd.
- Decided: Sep 3, 1999 after 606 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 K924081 (1992). 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)
- K924081: Lumisonic, Lumiscope Co., Inc. (1992) Summary page 2.

## Indications for use
The Shinmed Ultrasonic Nebulizer is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

Source page: https://510kreport.com/device/K980024
Methodology: https://510kreport.com/methodology