Cleared Traditional

BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM (K802198) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802198 · Biometric Analysis Group, Inc. · Cardiovascular device
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Sep 1980
Decision
16d
Days
Class 2
Risk

K802198 is an FDA 510(k) clearance for the BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Biometric Analysis Group, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biometric Analysis Group, Inc. devices

Submission Details

510(k) Number K802198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1980
Decision Date September 26, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 40
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K802198.
ANERIOD GAUZE
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K802305 · Nihon Kohden America, Inc. · Oct 1980
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K792678 · Nihon Kohden America, Inc. · Jan 1980
CARDIAC OUTPUT THERMODILUTION MODULE
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CARDIAC CATHETERIZATION LAB MONITOR SYS
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