# K031413: Vigormist Compressor Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Vega Technologies, Inc.
- Decided: Oct 7, 2003 after 155 days
- Product code: BTI (Compressor, Air, Portable)
- Device class: 2
- Regulation: 21 CFR 868.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914836 (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)
- K914836: Omron Compressor Nebulizer- Model NE-C09, Omron Healthcare, Inc. (1992) Summary page 1.
- K002831: Vega Ultrasonic Nebulizer, Vega Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K131881: Ombra Table Top Compressor (2013), 0 descendants of its own

## Recalls of this device
- Apr 20, 2015 · Class II · Z-1720-2015: Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform

## Indications for use
The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the WestMed VixOne) to convert certain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.

Source page: https://510kreport.com/device/K031413
Methodology: https://510kreport.com/methodology