Cleared Traditional

K013376 - QFLOW 500 PERFUSION MONITORING SYSTEM

K013376 is an FDA 510(k) clearance for QFLOW 500 PERFUSION MONITORING SYSTEM, manufactured by Hemedex Incorporated. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K013376 · Hemedex Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
209d
Days
Class 2
Risk

K013376 is an FDA 510(k) clearance for the QFLOW 500 PERFUSION MONITORING SYSTEM. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Hemedex Incorporated (Hopkonton, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 209 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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.

FDA 510(k) Submission Details - K013376

510(k) Number K013376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2001
Decision Date May 08, 2002
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 138
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K013376.
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K013376 · QFLOW 500 PERFUSION MONITORING SYSTEM
Download PDF FDA Summary Hemedex Incorporated