510(k) Report

Devices descending from K980878

19 later devices reach Pulmotrack,Model 1010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071955Wim-PC, Model 1010Karmelsonix200717—
+1K012387STG Multichannel Lung Sound Analysis SystemStethographics, Inc.20029—
+2K102229Pulmotrack 2020 SystemKarmelsonix20110—
+2K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix20106—
+2K090863Personal WheezometerKarmelsonix20098—
+3K131285SonosentryIsonea, Ltd.20147—
+3K110525Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd.20115—
+4K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd.20250—
+4K202062wheezo WheezeRate DetectorRespiri Limited20216—
+4K201077Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs20203—
+5K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd.20235—
+5K220893Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc.20222—
+6K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd.20234—
+6K223382AeviceMDAevice Health Pte., Ltd.20231—
+7K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd.20260—
+7K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd.20260—
+7K243603AeviceMDAevice Health Pte., Ltd.20250—
+7K240555Tyto Insights for Crackles DetectionTyto Care, Ltd.20241—
+8K243567Tyto Insights for Rhonchi DetectionTyto Care, Ltd.20250—