Cleared Traditional

K222216 - TruWave Disposable Pressure Transducer

K222216 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 150-day FDA review.

K222216 · Edwards Lifesciences, LLC · Cardiovascular device
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Dec 2022
Decision
150d
Days
Class 2
Risk

K222216 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 December 22, 2022 after a review of 150 days - an extended review cycle.

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 - K222216

510(k) Number K222216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date December 22, 2022
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
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 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K222216.
OptoMonitor 3
K251367 · Opsens, Inc. · Jan 2026
OptoMonitor 3
K241418 · Opsens, Inc. · Feb 2025
ACIST RXi System (016616)
K233904 · Acist Medical Systems, Inc. · Jul 2024
OptoMonitor 3
K202943 · Opsens, Inc. · Nov 2020
OptoMonitor 3
K193620 · Opsens, Inc. · Jun 2020
Comet II Pressure Guidewire
K193279 · Boston Scientific Corporation · Dec 2019