# K072634: Emg Triton -Comp,Model NCA01-XXX Series

- Pathway: 510(k) (Traditional)
- Applicant: Emg Technology Co., Ltd.
- Decided: Nov 19, 2008 after 428 days
- Product code: BTI (Compressor, Air, Portable)
- Device class: 2
- Regulation: 21 CFR 868.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K781213 (1978). 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)
- K781213: Compressor, Air, Mini-Silent, The John Bunn Co. (1978) Summary page 1.
- K900686: Maxi Compressors, Medical Industries America, Inc. (1990) Summary page 1.
- K963349: Devilbiss 8650D, Devilbiss Health Care, Inc. (1997) Summary page 1.

## Indications for use
The device is a portable air compressor intended to provide compressed air for medical purposes. It is used with a pneumatic nebulizer to administer humidified air or medication to the patient. The device is intended for use on adult and pediatric patients in a home health care or institutional environment. It's not approved for use with ventilators.

Source page: https://510kreport.com/device/K072634
Methodology: https://510kreport.com/methodology