510(k) Report

Devices descending from K193242

7 later devices reach Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+1K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+1K223498Radius VSM and AccessoriesMasimo Corporation202312
+1K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+1K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+2K250757Radius VSM and AccessoriesMasimo Corporation20250—
+2K231531Pediarity™Hinlab, Inc.20230—