# K240555: Tyto Insights for Crackles Detection

- Pathway: 510(k) (Traditional)
- Applicant: Tyto Care, Ltd.
- Decided: Jul 2, 2024 after 125 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: 7 generations back to K980878 (1998). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232237: Tyto Insights for Wheeze Detection, Tyto Care, Ltd. (2023) Summary page 5.

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

## Indications for use
The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Crackle” 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 Tyto Insights for Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

Source page: https://510kreport.com/device/K240555
Methodology: https://510kreport.com/methodology