Cleared Traditional

K821397 - ADULT INCONTINET BRIEF

K821397 is the FDA 510(k) clearance for ADULT INCONTINET BRIEF by Johnson & Johnson Professionals, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EYQ) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K821397 · Johnson & Johnson Professionals, Inc. · Gastroenterology & Urology device
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May 1982
Decision
13d
Days
Class 1
Risk

K821397 is an FDA 510(k) clearance for the ADULT INCONTINET BRIEF. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on May 24, 1982 after a review of 13 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K821397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date May 24, 1982
Days to Decision 13 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 130d · This submission: 13d
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.

Regulatory Peers - EYQ Garment, Protective, For Incontinence

All 15
Devices cleared under the same product code (EYQ) and FDA review panel - the closest regulatory comparables to K821397.
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
K845010 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
ADULT INCONTINENCE PAD
K834295 · Procter & Gamble Mfg. Co. · Feb 1984
ADULT INCONTINENCE BRIEF
K834296 · Procter & Gamble Mfg. Co. · Feb 1984
COMFORM ABSORBANT INCONTINENCE PADS
K781375 · Kimberly-Clark Corp. · Sep 1978
UNDERPAD CODE NO. 8453
K760277 · Johnson & Johnson Professionals, Inc. · Aug 1976
UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX)
K760164 · Parke-Davis Co. · Jul 1976