Cleared Traditional

K231248 - Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform (FDA 510(k) Clearance)

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

K231248 · Edwards Lifesciencess, LLC · Cardiovascular device
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Sep 2023
Decision
143d
Days
Class 2
Risk

K231248 is an FDA 510(k) clearance for the Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Adv.... Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Edwards Lifesciencess, LLC (Irvine, US). The FDA issued a Cleared decision on September 21, 2023 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Lifesciencess, LLC devices

Submission Details

510(k) Number K231248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date September 21, 2023
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 98
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K231248.
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
K242451 · Edwards Lifesciences · Dec 2024
Swan-Ganz Pacing Probe and Catheters
K233983 · Edwards Lifesciences · Jun 2024
Swan-Ganz catheter
K233824 · Edwards Lifesciences, LLC · Jun 2024
Swang-Ganz IQ pulmonary artery catheter
K222117 · Edwards Lifesiences, LLC · Dec 2022