Cleared Traditional

INDONTINENCE PAD (K853741) - FDA 510(k) Clearance

K853741 · Beghin_Say Intl., Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
69d
Days
-
Risk

K853741 is an FDA 510(k) clearance for the INDONTINENCE PAD.

Submitted by Beghin_Say Intl., Inc. (Lakeland, US). The FDA issued a Cleared decision on November 14, 1985 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Beghin_Say Intl., Inc. devices

Submission Details

510(k) Number K853741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date November 14, 1985
Days to Decision 69 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
61d faster than avg
Panel avg: 130d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -