# K131881: Ombra Table Top Compressor

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Intl.
- Decided: Oct 24, 2013 after 121 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: 3 generations back to K963924 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031413: Vigormist Compressor Nebulizer, Vega Technologies, Inc. (2003) Summary page 1.
- K092918: Pari Vios, Pari Respiratory Equipment, Inc. (2010) Summary page 1.

## Indications for use
The Ombra* Table Top Compressor is designed to deliver compressed air to a jet or pneumatic nebulizer. This compressor may be used with adult, child or pediatric patients. The Ombra* Table Top Compressor is a medical device, and should only be used as directed by your healthcare professional. The intended environments for use include the home, hospitals and clinics.

Source page: https://510kreport.com/device/K131881
Methodology: https://510kreport.com/methodology