Cleared Traditional

K142749 - TruWave Disposable Pressure Transducer

K142749 is an FDA 510(k) clearance for TruWave Disposable Pressure Transducer, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K142749 · Edwards Lifesciences, LLC · Cardiovascular device
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Jan 2015
Decision
116d
Days
Class 2
Risk

K142749 is an FDA 510(k) clearance for the TruWave Disposable Pressure Transducer. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on January 18, 2015 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K142749

510(k) Number K142749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2014
Decision Date January 18, 2015
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXO Transducer, Pressure, Catheter Tip

All 33
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K142749.
TruWave Disposable Pressure Transducer
K171996 · Edwards Lifesciences, LLC · Oct 2017
PressureWire X Guidewire
K161171 · St. Jude Medical, Inc. · Aug 2016
Comet Pressure Guidewire
K151610 · Boston Scientific Corporation · Oct 2015
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · St Jude Medical · Mar 2012
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · Radi Medical Systems AB · Jul 2008