Cleared Traditional

K100739 - VOLUMEVIEW SYSTEM

K100739 is an FDA 510(k) clearance for VOLUMEVIEW SYSTEM, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K100739 · Edwards Lifesciences, LLC · Cardiovascular device
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Dec 2010
Decision
266d
Days
Class 2
Risk

K100739 is an FDA 510(k) clearance for the VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on December 7, 2010 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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 - K100739

510(k) Number K100739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2010
Decision Date December 07, 2010
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRB Device Classification - Class 2, Special Controls

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 18
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K100739.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · NuMED, Inc. · Sep 1988
ACKRAD TDI SET
K864818 · Ackrad Laboratories · Apr 1987
HEPARIN COATED THERMODILUTION CATHETERS
K840824 · Gould, Inc. · May 1984