# K091732: Vrlxp, Model XP

- Pathway: 510(k) (Traditional)
- Applicant: Deep Breeze, Ltd.
- Decided: Mar 4, 2010 after 266 days
- Product code: OCR (Lung Sound Monitor)
- Device class: 2
- Regulation: 21 CFR 870.1875
- 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 K771653 (1977). 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)
- K073582: Vriicu System, Deep Breeze, Ltd. (2008) Summary page 1.
- K061495: VR Lung Electrosonograph, Deep Breeze, Ltd. (2007) Summary page 1.
- K991367: Meditron Stethoscope System, Meditron AS (1999) Summary page 2.

## Indications for use
The VR1xp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRlxp aids in diagnosis and patient management. The VRlxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.

Source page: https://510kreport.com/device/K091732
Methodology: https://510kreport.com/methodology