510(k) Report

Devices descending from K012387

9 later devices reach STG Multichannel Lung Sound Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090863Personal WheezometerKarmelsonix20098—
+2K131285SonosentryIsonea, Ltd.20147—
+3K202062wheezo WheezeRate DetectorRespiri Limited20216—
+4K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd.20235—
+5K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd.20234—
+6K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd.20260—
+6K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd.20260—
+6K240555Tyto Insights for Crackles DetectionTyto Care, Ltd.20241—
+7K243567Tyto Insights for Rhonchi DetectionTyto Care, Ltd.20250—