Cleared Traditional

K082163 - FLOWMEDICA BENEPHIT INFUSION SYSTEMS

K082163 is an FDA 510(k) clearance for FLOWMEDICA BENEPHIT INFUSION SYSTEMS, manufactured by Flowmedica, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K082163 · Flowmedica, Inc. · Cardiovascular device
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Oct 2008
Decision
90d
Days
Class 2
Risk

K082163 is an FDA 510(k) clearance for the FLOWMEDICA BENEPHIT INFUSION SYSTEMS. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Flowmedica, Inc. (Fremont, US). The FDA issued a Cleared decision on October 29, 2008 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Flowmedica, Inc. devices

FDA 510(k) Submission Details - K082163

510(k) Number K082163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2008
Decision Date October 29, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 137
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K082163.
CROSSCATH SUPPORT CATHTER
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MERIT MICROCATHETER
K082613 · Merit Medical Systems, Inc. · Dec 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · Terumo Medical Corp. · Sep 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · Cook, Inc. · Aug 2008
ENDOWAVE INFUSION SYSTEM
K073166 · Ekos Corp. · Apr 2008