# K141495: Truwave Disposable Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Sep 3, 2014 after 89 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925638 (1993). 1 ancestor in all.
14 later devices descend from it; 2 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)
- K925638: Phoenix Disposable Pressure Transducer #73-600, Baxter Healthcare Corp (1993) Summary page 20.

## Most influential descendants
- K142749: TruWave Disposable Pressure Transducer (2015), 13 descendants of its own
- 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

## 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/K141495
Methodology: https://510kreport.com/methodology