510(k) Report

Devices descending from K131285

7 later devices reach Sonosentry through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202062wheezo WheezeRate DetectorRespiri Limited20216—
+2K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd.20235—
+3K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd.20234—
+4K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd.20260—
+4K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd.20260—
+4K240555Tyto Insights for Crackles DetectionTyto Care, Ltd.20241—
+5K243567Tyto Insights for Rhonchi DetectionTyto Care, Ltd.20250—