Cleared Traditional

K771655 - CURITY PEAKOMETER

K771655 is the FDA 510(k) clearance for CURITY PEAKOMETER by Kendall Research Center. It is a Class 2 Gastroenterology & Urology device (product code FFG) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K771655 · Kendall Research Center · Gastroenterology & Urology device
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Oct 1977
Decision
46d
Days
Class 2
Risk

K771655 is an FDA 510(k) clearance for the CURITY PEAKOMETER. Classified as Device, Urine Flow Rate Measuring, Non-electrical, Disposable (product code FFG), Class II - Special Controls.

Submitted by Kendall Research Center (Mchenry, US). The FDA issued a Cleared decision on October 14, 1977 after a review of 46 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.

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Submission Details

510(k) Number K771655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1977
Decision Date October 14, 1977
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFG Device, Urine Flow Rate Measuring, Non-electrical, Disposable
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.