Cleared Traditional

K970570 - NIVP3 (WINDOWS VERSION OF NIVP

K970570 is the FDA 510(k) clearance for NIVP3 (WINDOWS VERSION OF NIVP by D. E. Hokanson, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K970570 · D. E. Hokanson, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
231d
Days
Class 2
Risk

K970570 is an FDA 510(k) clearance for the NIVP3 (WINDOWS VERSION OF NIVP. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Bellevue, US). The FDA issued a Cleared decision on October 3, 1997 after a review of 231 days - an extended review cycle.

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 D. E. Hokanson, Inc. devices

Submission Details

510(k) Number K970570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1997
Decision Date October 03, 1997
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
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

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