Cleared Traditional

MOLINEA INCONTINENT PAD (K843404) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K843404 · Paul Hartmann Corp. · Gastroenterology & Urology device
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Oct 1984
Decision
50d
Days
Class 1
Risk

K843404 is an FDA 510(k) clearance for the MOLINEA INCONTINENT PAD. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Paul Hartmann Corp. (Greenwood, US). The FDA issued a Cleared decision on October 19, 1984 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5920 - 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 Paul Hartmann Corp. devices

Submission Details

510(k) Number K843404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1984
Decision Date October 19, 1984
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYQ Garment, Protective, For Incontinence
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5920
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.