Cleared Traditional

K160645 - PreSep Oligon Oximetry Catheter

K160645 is an FDA 510(k) clearance for PreSep Oligon Oximetry Catheter, 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 101-day FDA review.

K160645 · Edwards Lifesciences, LLC · Cardiovascular device
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Jun 2016
Decision
101d
Days
Class 2
Risk

K160645 is an FDA 510(k) clearance for the PreSep Oligon Oximetry Catheter. 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 June 16, 2016 after a review of 101 days - within the typical 510(k) review window.

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: 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 - K160645

510(k) Number K160645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date June 16, 2016
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 K160645.
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
K172423 · Edwards Lifescience, LLC · Feb 2018
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
K140129 · Icu Medical, Inc. · Jul 2014
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · Edwards Lifesciences, LLC · Feb 2011
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
K091268 · Hospira, Inc. · Sep 2009
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
K062999 · Hospira, Inc. · Nov 2006
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
K061585 · Hospira, Inc. · Oct 2006