510(k) Report

Devices descending from K982255

816 later devices reach Model 2000 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231531Pediarity™Hinlab, Inc.20230—
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K223905Vivio® LVEDP SystemAvicena, LLC20230—
+10K231335Cleerly ISCHEMIACleerly, Inc.20230—
+10K231276SmartCardia 7L PlatformSmartcardia SA20230—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K212271smart-syncNorthh Medical GmbH20220—
+10K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+10K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+10K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+10K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+11K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+11K254066Etiometry PlatformEtiometry, Inc.20260—
+11K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+11K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302