510(k) Report

Devices descending from K021573

52 later devices reach Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp.20066Class I
+1K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa2005511
+2K103578Philips NM3 Respiratory Monitor with VentassistRespironics Novametrix, LLC20114—
+2K100941Infinity Mcable - Mainstream CO2Draeger Medical AG & Co. KG20101—
+2K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa201010Class I
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa200823—
+2K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070—
+2K061094Newport E500 Wave VentilatorNewport Medical Instruments, Inc.20062—
+2K061090Galileo Gold AsvHamilton Medical AG200636—
+3K222207Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa20230—
+3K221118CO2 Mainstream SensorDraegerwerk AG & CO Kgaa20230—
+3K222897Enlight 2100Timpel S.A.20232—
+3K192584BEACON Caresystem Model 00002144Mermaid Care A/S20190—
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K103803Hamilton-G5Hamilton Medical AG201114Class I
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K101803Newport E360 VentilatorNewport Medical Instruments, Inc.20101—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+3K080181Modification to Galileo GoldHamilton Medical AG200821—
+3K070513Hamilton-G5Hamilton Medical AG2007261
+3K071194Raphael Color Asv VentilatorHamilton Medical AG20070—
+4K250464Enlight 2100 (TPL-E2103-0)Timpel S.A.20250—
+4K243765LuMon (TM) SystemSentec AG20250—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K131774Hamilton-G5Hamilton Medical AG201310Class I
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+4K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+4K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K180295Hamilton-G5Hamiton Medical AG20192—
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+5K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K103211Avea VentilatorCare Fusion20115Class I
+6K210384Carescape R860Datex-Ohmeda, Inc.20210—
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+6K193228Hamilton-G5Hamilton Medical AG20201—
+6K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+6K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+7K233486731 Series VentilatorZOLL Medical Corporation20240—
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+8K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I