510(k) Report

Devices descending from K190008

11 later devices reach Carescape One through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESGE Healthcare2020101
+2K223498Radius VSM and AccessoriesMasimo Corporation202312
+2K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG…Ge Medical Systems Information Technologies, Inc.202231
+2K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+2K212876Carescape SpO2 - MasimoMasimo Corporation20212—
+3K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+3K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+3K250757Radius VSM and AccessoriesMasimo Corporation20250—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+3K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+4K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—