# K243468: Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Jul 2, 2025 after 236 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 K914836 (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)
- K110860: Comp a-I-R, Omron Healthcare, Inc. (2011) Summary page 5.

## Indications for use
The Compressor Nebulizer system is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The nebulizer is driven by the integral air compressor. The system is designed for use with pediatric (ages 2 years and above) and adult patients in the home, hospital, and sub-acute settings.

Source page: https://510kreport.com/device/K243468
Methodology: https://510kreport.com/methodology