# K152980: Flo Trac sensor, Volume View sensor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 19, 2016 after 102 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925638 (1993). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043065: Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1P, Edwards Lifesciences, LLC (2005) Summary page 4.
- K142749: TruWave Disposable Pressure Transducer, Edwards Lifesciences, LLC (2015) Summary page 4.
- (no number) FloTrac Sensor: named in the summary without a submission number
- (no number) VolumeView Sensor: named in the summary without a submission number

## Most influential descendants
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (2023), 6 descendants of its own
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), 4 descendants of its own
- K243781: HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) (2025), 2 descendants of its own
- K253186: HemoSphere Nano Monitor (HSNANO1) (2026), 0 descendants of its own
- K252533: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (2025), 0 descendants of its own

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0411-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- Oct 4, 2023 · Class II · Z-0410-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- Oct 4, 2023 · Class II · Z-0409-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- Oct 4, 2023 · Class II · Z-0412-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

## Indications for use
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.

Source page: https://510kreport.com/device/K152980
Methodology: https://510kreport.com/methodology