Class Class II
TytoCare Lung Sounds Analyzer (K221614)
Description
TytoCare Lung Sounds Analyzer by Tyto Care , Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221614
Clearance Date2023-02-24
Clearance TypeTraditional
Product CodePHZ
Regulation Number868.1900
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221614
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TytoCare Lung Sounds Analyzer (K221614) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 |
| K181612 | Tyto Stethoscope (OTC) | Tyto Care , Ltd. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240555 | Tyto Insights for Crackles Detection | Tyto Care , Ltd. | 2024 |
| K232237 | Tyto Insights for Wheeze Detection | Tyto Care , Ltd. | 2023 |
Trace the full predicate network for K221614
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.