510(k) Report

Devices descending from K142749

13 later devices reach TruWave Disposable Pressure Transducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183413TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC201912
+1K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC201741
+1K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC201674
+2K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+2K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+2K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC20220—
+2K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC20181—
+3K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+3K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC201801
+4K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+4K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+5K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+5K253034HemoSphere Stream ModuleEdwards Lifesciences20250—