# K052438: Emg Handle Nebulizer NB02 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Emg Technology Co., Ltd.
- Decided: Jan 31, 2006 after 147 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K112824: Quality Life Technologies Compressor Nebulizer (2012), 0 descendants of its own

## Indications for use
The Handle Nebulizer is a disposable device, which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with Nebulizers.

Source page: https://510kreport.com/device/K052438
Methodology: https://510kreport.com/methodology