Cleared Traditional

K872022 - UROVIEW (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K872022 · Oec-Diasonics, Inc. · Gastroenterology & Urology device
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Jul 1987
Decision
51d
Days
Class 1
Risk

K872022 is an FDA 510(k) clearance for the UROVIEW. Classified as Table, Cystometric, Non-electric And Accessories (product code KQS), Class I - General Controls.

Submitted by Oec-Diasonics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 16, 1987 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4890 - 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 Oec-Diasonics, Inc. devices

Submission Details

510(k) Number K872022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date July 16, 1987
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQS Table, Cystometric, Non-electric And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4890
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.