Cleared Traditional

DILECTRON URINARY CONDUCTIVITY PROBE (K891681) - FDA 510(k) Clearance

Class I Chemistry device.

K891681 · Gyrus Medical , Ltd. · Chemistry device
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May 1990
Decision
405d
Days
Class 1
Risk

K891681 is an FDA 510(k) clearance for the DILECTRON URINARY CONDUCTIVITY PROBE. Classified as Refractometer For Clinical Use (product code JRE), Class I - General Controls.

Submitted by Gyrus Medical , Ltd. (England, GB). The FDA issued a Cleared decision on May 1, 1990 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Gyrus Medical , Ltd. devices

Submission Details

510(k) Number K891681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1989
Decision Date May 01, 1990
Days to Decision 405 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
317d slower than avg
Panel avg: 88d · This submission: 405d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRE Refractometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2800
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.