# K053490: Merits Health Products Portable Nebulizer

- Pathway: 510(k) (Abbreviated)
- Applicant: Merits Health Products Co., Ltd.
- Decided: Jul 24, 2006 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: 1 generation back to K914836 (1992). 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)
- K914836: Omron Compressor Nebulizer- Model NE-C09, Omron Healthcare, Inc. (1992) Summary page 1.
- K021742: Galemed Neb-Easy Nebulizer, Galemed Corp. (2002) Summary page 1.

## Indications for use
The Merits Health Products Portable Nebulizers are designed to deliver the prescribed liquid medication to treat patients' respiratory disorders, such as asthma, allergies, and bronchitis. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Source page: https://510kreport.com/device/K053490
Methodology: https://510kreport.com/methodology