# K171996: TruWave Disposable Pressure Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 23, 2017 after 112 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: 1 (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). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 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.
- K142749: TruWave Disposable Pressure Transducer, Edwards Lifesciences, LLC (2015) Summary page 4.

## Most influential descendants
- K183413: TruWave Disposable Pressure Transducer (2019), 1 descendant of its own
- K173586: VAMP Venous/Arterial Blood Management Protection System (2018), 1 descendant of its own
- K222216: TruWave Disposable Pressure Transducer (2022), 0 descendants of its own
- K181684: VAMP Plus Venous/Arterial Blood Management Protection System (2018), 0 descendants of its own

## Recalls of this device
- 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.

## 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/K171996
Methodology: https://510kreport.com/methodology