# K221614: TytoCare Lung Sounds Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Tyto Care, Ltd.
- Decided: Feb 24, 2023 after 266 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: 5 generations back to K980878 (1998). 6 ancestors in all.
5 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)
- K202062: wheezo WheezeRate Detector, Respiri Limited (2021) Summary page 4.

## Most influential descendants
- 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
- K252844: Tyto Insights for Wheeze Detection (with PCCP) (2026), 0 descendants of its own
- K243567: Tyto Insights for Rhonchi Detection (2025), 0 descendants of its own

## Indications for use
The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.

Source page: https://510kreport.com/device/K221614
Methodology: https://510kreport.com/methodology