# K192633: GUS831 Compressor Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Globalcare Medical Technology Co., Ltd.
- Decided: May 1, 2020 after 221 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: 2 generations back to K990435 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121969: U-Right Compressor Nebulizer, Taidoc Technology Corporation (2013) Summary page 4.

## Indications for use
GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.

Source page: https://510kreport.com/device/K192633
Methodology: https://510kreport.com/methodology