# K081738: Ultrasonic Nebulizer System, Model HL100

- Pathway: 510(k) (Traditional)
- Applicant: Health & Life Co., Ltd.
- Decided: Sep 17, 2008 after 90 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 K923024 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062263: Omron Micro-Air Vibrating Mesh Nebulizer, Model NE-U22, Omron Healthcare, Inc. (2007) Summary page 1.

## Most influential descendants
- K090307: Ddi Ultrasonic Nebulizer System (2009), 0 descendants of its own

## Indications for use
The HL100 Ultrasonic Nebulizer System utillizes the state-of-the-art elecctrospray technology that sprays liquid medication in aerosol form and deliveries it directly to the adult and pediatric patients who suffer from asthma, Chronic Obstructive Pulmonary Disease (COPD) such as emphysema and chronic bronchitis, or other respiratory diseases that are characterized by obstruction to air flow for breathing.

Source page: https://510kreport.com/device/K081738
Methodology: https://510kreport.com/methodology