Cleared Traditional

K770939 - URINE TESTER

K770939 is the FDA 510(k) clearance for URINE TESTER by Brother Scientific Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EXR) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K770939 · Brother Scientific Products, Inc. · Gastroenterology & Urology device
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Jun 1977
Decision
11d
Days
Class 2
Risk

K770939 is an FDA 510(k) clearance for the URINE TESTER, MODEL 701. Classified as Urinometer, Mechanical (product code EXR), Class II - Special Controls.

Submitted by Brother Scientific Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1977 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1800 - 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: 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 Brother Scientific Products, Inc. devices

Submission Details

510(k) Number K770939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1977
Decision Date June 03, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 130d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EXR Urinometer, Mechanical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1800
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.