# K041079: Guan Hong Ultrasonic Nebulizer, Model DR-103/AC-103

- Pathway: 510(k) (Traditional)
- Applicant: Guan Hong Enterprise Co., Ltd.
- Decided: Sep 28, 2004 after 155 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 K990506 (1999). 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)
- K990506: Mabis NB-02 Ultrasonic Nebulizer, Mabis Healthcare, Inc. (1999) Summary page 5.

## Indications for use
The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is an ultrasonic nebulizer that is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. The GUAN HONG Model# AC103/DR 103 Ultrasonic Nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Source page: https://510kreport.com/device/K041079
Methodology: https://510kreport.com/methodology