# K090307: Ddi Ultrasonic Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Devices, Inc.
- Decided: Jun 18, 2009 after 132 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: 3 generations back to K923024 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K081738: Ultrasonic Nebulizer System, Model HL100, Health & Life Co., Ltd. (2008) Summary page 1.

## Indications for use
The DDI Ultrasonic Nebulizer System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub- acute care settings.

Source page: https://510kreport.com/device/K090307
Methodology: https://510kreport.com/methodology