Cleared Traditional

K840827 - KYOTEST 5V

K840827 is an FDA 510(k) clearance for KYOTEST 5V, manufactured by Kyoto Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CEN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K840827 · Kyoto Diagnostics, Inc. · Chemistry device
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May 1984
Decision
80d
Days
Class 1
Risk

K840827 is an FDA 510(k) clearance for the KYOTEST 5V. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Kyoto Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on May 14, 1984 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - the FDA in vitro diagnostics and chemistry 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 Kyoto Diagnostics, Inc. devices

FDA 510(k) Submission Details - K840827

510(k) Number K840827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date May 14, 1984
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

CEN Device Classification - Class 1, General Controls

Product Code CEN Dye-indicator, Ph (urinary, Non-quantitative)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
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.

Regulatory Peers - CEN Dye-indicator, Ph (urinary, Non-quantitative)

All 7
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