# K083256: Ultrasonic Nebulizer System, Model KN-9210

- Pathway: 510(k) (Abbreviated)
- Applicant: K-Jump Health Co., Ltd.
- Decided: Jun 26, 2009 after 234 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: 5 generations back to K870027 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051365: Compressor Nebulizer System, Model KN-9321, K-Jump Health Co., Ltd. (2005) Summary page 1.
- K974379: Ultraneb, Bremed Italia, S.R.L. (1998) Summary page 1.

## Indications for use
K-jump Health Co., Ltd. Ultrasonic Nebulizer System includes a DC powered ceramic resonator and a fan that provides a source of mist for home health care use. The device is used with a pneumatic nebulizer to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Source page: https://510kreport.com/device/K083256
Methodology: https://510kreport.com/methodology