Cleared Traditional

K053609 - PRESEP AND PEDIASAT OXIMETRY CATHETERS ...

K053609 is an FDA 510(k) clearance for PRESEP AND PEDIASAT OXIMETRY CATHETERS ..., manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DQE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K053609 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
63d
Days
Class 2
Risk

K053609 is an FDA 510(k) clearance for the PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC .... Classified as Catheter, Oximeter, Fiber-optic (product code DQE), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on February 28, 2006 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1230 - 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 - K053609

510(k) Number K053609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2005
Decision Date February 28, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQE Device Classification - Class 2, Special Controls

Product Code DQE Catheter, Oximeter, Fiber-optic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1230
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 - DQE Catheter, Oximeter, Fiber-optic

All 14
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K053609.
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K060093 · Edwards Lifesciences, LLC · Apr 2006
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
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