Cleared Traditional

K840754 - MAXISHIELD INCONTINENCE CARE SYSTEM

K840754 is an FDA 510(k) clearance for MAXISHIELD INCONTINENCE CARE SYSTEM, manufactured by Ipco Corp.. The device is a Class 1 Gastroenterology & Urology device with product code EYQ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K840754 · Ipco Corp. · Gastroenterology & Urology device
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Apr 1984
Decision
50d
Days
Class 1
Risk

K840754 is an FDA 510(k) clearance for the MAXISHIELD INCONTINENCE CARE SYSTEM. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Ipco Corp. (Walker, US). The FDA issued a Cleared decision on April 13, 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 Ipco Corp. devices

FDA 510(k) Submission Details - K840754

510(k) Number K840754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date April 13, 1984
Days to Decision 50 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
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

EYQ Device Classification - Class 1, General Controls

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 21
Devices cleared under the same product code (EYQ) and FDA review panel - the closest regulatory comparables to K840754.
CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH
K845010 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
ULTRA SHIELD BRIEFS
K841953 · Ipco Corp. · Jul 1984
AMBEZE DISPOSABLE INCONTINENCE PANTS
K840753 · Ipco Corp. · Apr 1984
MINIGARD DISPOSABLE LINERS
K840755 · Ipco Corp. · Apr 1984
ADULT INCONTINENCE PAD
K834295 · Procter & Gamble Mfg. Co. · Feb 1984
ADULT INCONTINENCE BRIEF
K834296 · Procter & Gamble Mfg. Co. · Feb 1984