Cleared Traditional

K830220 - YELLOW IRIS TM (FDA 510(k) Clearance)

Class I Pathology device.

K830220 · Intl. Remote Imaging Systems · Pathology device
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Jun 1983
Decision
144d
Days
Class 1
Risk

K830220 is an FDA 510(k) clearance for the YELLOW IRIS TM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Intl. Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on June 17, 1983 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2900 - the FDA pathology device 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K830220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1983
Decision Date June 17, 1983
Days to Decision 144 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 77d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.