# K242909: FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Mar 21, 2025 after 178 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K941811 (1994). 261 ancestors in all.
No later device cites it as a predicate yet.
2 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152980: Flo Trac sensor, Volume View sensor, Edwards Lifesciences, LLC (2016) Summary page 5.
- K231248: Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform, Edwards Lifesciencess, LLC (2023) Summary page 5.

## 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. They are intended to be used in adult patients. The FloTrac Jr 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 FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age. The Acumen IQ 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. They are intended to be used in adult patients. 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/K242909
Methodology: https://510kreport.com/methodology