510(k) Report

Devices descending from K181612

19 later devices reach Tyto Stethoscope (OTC) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252089Tyto Stethoscope (G3)Tyto Care, Ltd.20260—
+1K252474Withings BeamO (SCT02)Withings20250—
+1K223785N9+Nonagon, Ltd.20230—
+1K212906HeartBuds Electronic StethoscopeHeartbuds, LLC20230—
+1K223166Medaica M1 Telehealth StethoscopeMedaica, Inc.20230—
+1K200776Eko COREEko Devices, Inc.202013—
+2K261694CORE 300 Digital StethoscopeEko Health, Inc.20260—
+2K233313Keikku Electronic stethoscopeLapsi Health Holding B.V.20240—
+2K231551StethophoneSparrow Acoustics, Inc.20232—
+2K230613SkeeperSmartsound Corporation20230—
+2K220099eClinic StethopodHomediagnostic, LLC20220—
+2K220470Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd.20221—
+2K220196Steth IO SpotStratoscientific20220—
+2K210736doctorgram Stethoscope DES-IGv Concepts20212—
+3K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…Shanghai Hulu Devices Co., Ltd.20260—
+3K240901StethophoneSparrow Acoustics, Inc.20241—
+3K212975MedWandMedwand Solutions, Inc.20221—
+4K253436c-med0 alphaCosinuss GmbH20260—
+4K252595Stethophone ProSparrow Acoustics, Inc.20250—