510(k) Report

Devices descending from K180046

13 later devices reach Masimo Rad-97 and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+1K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+1K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+1K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+2K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+2K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+3K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+3K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+3K223498Radius VSM and AccessoriesMasimo Corporation202312
+3K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+3K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+4K250757Radius VSM and AccessoriesMasimo Corporation20250—
+4K231531Pediarity™Hinlab, Inc.20230—