Cleared Traditional

URODYN 1000 (K853119) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K853119 · Dantec Electronics, Inc. · Gastroenterology & Urology device
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Oct 1985
Decision
71d
Days
Class 1
Risk

K853119 is an FDA 510(k) clearance for the URODYN 1000. Classified as Retractor, Self-retaining (product code FFO), Class I - General Controls.

Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Dantec Electronics, Inc. devices

Submission Details

510(k) Number K853119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1985
Decision Date October 04, 1985
Days to Decision 71 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
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFO Retractor, Self-retaining
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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.