510(k) Report

Devices descending from K092101

7 later devices reach Reusable Pulse Oximeter Sensor, Model 8000 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+1K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+2K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+2K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+2K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+2K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+3K233827OxiWearOxiwear, Inc.20240—