Cleared Traditional

RH VIEWBOX (K792306) - FDA 510(k) Clearance

Class I Hematology device.

K792306 · Tekpro · Hematology device
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Dec 1979
Decision
18d
Days
Class 1
Risk

K792306 is an FDA 510(k) clearance for the RH VIEWBOX. Classified as Boxes, View, Blood Grouping (product code KSY), Class I - General Controls.

Submitted by Tekpro (Mchenry, US). The FDA issued a Cleared decision on December 4, 1979 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9185 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K792306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1979
Decision Date December 04, 1979
Days to Decision 18 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 113d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KSY Boxes, View, Blood Grouping
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.9185
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.