# K031370: Shinmed Mode SW-988 Untrasonic Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Shining World Health Care Co., Ltd.
- Decided: Sep 1, 2004 after 490 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 Shinmed Ultrasonic Nebulizer SW-988 is intended to spray liquid medications in aerosol form into gases that are directly delivered to the patient.

Source page: https://510kreport.com/device/K031370
Methodology: https://510kreport.com/methodology