# K131285: Sonosentry

- Pathway: 510(k) (Traditional)
- Applicant: Isonea, Ltd.
- Decided: Aug 19, 2014 after 470 days
- Product code: PHZ (Abnormal Breath Sound Device)
- Device class: 2
- Regulation: 21 CFR 868.1900
- 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 K980878 (1998). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090863: Personal Wheezometer, Karmelsonix (2009) Summary page 5.

## Most influential descendants
- K202062: wheezo WheezeRate Detector (2021), 6 descendants of its own
- K221614: TytoCare Lung Sounds Analyzer (2023), 5 descendants of its own
- K232237: Tyto Insights for Wheeze Detection (2023), 4 descendants of its own
- K240555: Tyto Insights for Crackles Detection (2024), 1 descendant of its own
- K260140: Aevice Wheeze Detection Module (2026), 0 descendants of its own

## Indications for use
The SonoSentryTM WheezeRateTM Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRateTM in adults and children (2 years and older). WheezeRateTM represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional’s advice is required to understand the meaning and importance of the SonoSentryTM readings.

Source page: https://510kreport.com/device/K131285
Methodology: https://510kreport.com/methodology