Cleared Traditional

K021495 - QIVA

K021495 is the FDA 510(k) clearance for QIVA by Pie Medical Imaging BV. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K021495 · Pie Medical Imaging BV · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
145d
Days
Class 2
Risk

K021495 is an FDA 510(k) clearance for the QIVA. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Pie Medical Imaging BV (Indianpolis, US). The FDA issued a Cleared decision on October 1, 2002 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Pie Medical Imaging BV devices

Submission Details

510(k) Number K021495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date October 01, 2002
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 247
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K013083 · Biosense Webster, Inc. · Nov 2001
SYNETEC
K002817 · Ela Medical, Inc. · May 2001