Cleared Traditional

K053016 - WIRELESS PHYSIOLOGIC MONITORING SYSTEM

K053016 is an FDA 510(k) clearance for WIRELESS PHYSIOLOGIC MONITORING SYSTEM, 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 65-day FDA review.

K053016 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
65d
Days
Class 2
Risk

K053016 is an FDA 510(k) clearance for the WIRELESS PHYSIOLOGIC MONITORING SYSTEM. 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 30, 2005 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K053016

510(k) Number K053016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date December 30, 2005
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 K053016.
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · Radi Medical Systems AB · Jul 2008
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
K070487 · Volcano Corporation · Mar 2007
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · Radi Medical Systems AB · Dec 2006
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · Radi Medical Systems AB · Jun 2003
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · Radi Medical Systems AB · Sep 2002
INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · Becton Dickinson Vascular Access, Inc. · Apr 1994