Cleared Traditional

SAFESEAL REUSABLE URINAL SYSTEM (K851682) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K851682 · Dbt Medical , Ltd. · Gastroenterology & Urology device
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Jun 1985
Decision
62d
Days
Class 1
Risk

K851682 is an FDA 510(k) clearance for the SAFESEAL REUSABLE URINAL SYSTEM. Classified as Device, Incontinence, Urosheath Type, Sterile (product code EXJ), Class I - General Controls.

Submitted by Dbt Medical , Ltd. (Witney,0x8 7az, GB). The FDA issued a Cleared decision on June 24, 1985 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Dbt Medical , Ltd. devices

Submission Details

510(k) Number K851682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date June 24, 1985
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXJ Device, Incontinence, Urosheath Type, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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.