Cleared Traditional

90DX MULTITEST METER, MODIFICATION (K925210) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K925210 · Mesa Medical, Inc. · Gastroenterology & Urology device
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Jan 1994
Decision
475d
Days
Class 2
Risk

K925210 is an FDA 510(k) clearance for the 90DX MULTITEST METER, MODIFICATION. Classified as Meter, Conductivity, Induction, Remote Type (product code FLB), Class II - Special Controls.

Submitted by Mesa Medical, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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: 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 Gastroenterology & Urology submissions.

View all Mesa Medical, Inc. devices

Submission Details

510(k) Number K925210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1992
Decision Date January 25, 1994
Days to Decision 475 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 130d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLB Meter, Conductivity, Induction, Remote Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.