510(k) Report

Devices descending from K101995

7 later devices reach Capnostream 20P with Masimo SPO2 Board through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112368CAPNOSTREAM20P with AI/OdiOridion Medical 1987, Ltd.201266
+2K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+2K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+3K213911Microstream CO2 NanoPodCovidien, LLC20220—
+3K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+3K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+4K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—