Cleared Traditional

PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 7
Devices cleared under the same product code (DQE) and FDA review panel - the closest regulatory comparables to K053609.
PreSep Oligon Oximetry Catheter
K160645 · Edwards Lifesciences, LLC · Jun 2016
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · Edwards Lifesciences, LLC · Feb 2011
PRESEP OLIGON OXIMETRY CATHETERS
K060093 · Edwards Lifesciences, LLC · Apr 2006
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450 · Baxter Healthcare Corp · Feb 1993
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
K905458 · Baxter Healthcare Corp · Feb 1991
OXIMETRY PROBE CATHETERS
K901736 · Baxter Healthcare Corp · Sep 1990