Cleared Traditional

K840996 - URINE ANALYZER SYSTEM

K840996 is the FDA 510(k) clearance for URINE ANALYZER SYSTEM by Kyoto Diagnostics, Inc.. It is a Class 1 Chemistry device (product code KQO) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K840996 · Kyoto Diagnostics, Inc. · Chemistry device
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May 1984
Decision
54d
Days
Class 1
Risk

K840996 is an FDA 510(k) clearance for the URINE ANALYZER SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Kyoto Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on May 1, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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

Submission Details

510(k) Number K840996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1984
Decision Date May 01, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 88d · This submission: 54d
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.

Regulatory Peers - KQO Automated Urinalysis System

All 22
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K840996.
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · Miles Laboratories, Inc. · Jul 1984
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · Miles Laboratories, Inc. · Jul 1982
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · Miles Laboratories, Inc. · Mar 1977
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472 · Miles Laboratories, Inc. · Oct 1976