# K142749: TruWave Disposable Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 18, 2015 after 116 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925638 (1993). 2 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141495: Truwave Disposable Pressure Transducer, Edwards Lifesciences, LLC (2014) Summary page 4.

## Most influential descendants
- K152980: Flo Trac sensor, Volume View sensor (2016), 7 descendants of its own
- 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
- K171996: TruWave Disposable Pressure Transducer (2017), 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

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0414-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- Oct 4, 2023 · Class II · Z-0413-2024: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
- May 26, 2021 · Class II · Z-1960-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1963-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1964-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1961-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1966-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1962-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1965-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- May 26, 2021 · Class II · Z-1959-2021: There is a potential that the pressure tubing may detach from the blood sampling system
- Jul 31, 2015 · Class II · Z-2776-2015: Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or di

## Indications for use
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

Source page: https://510kreport.com/device/K142749
Methodology: https://510kreport.com/methodology