Cleared Traditional

K841953 - ULTRA SHIELD BRIEFS

K841953 is the FDA 510(k) clearance for ULTRA SHIELD BRIEFS by Ipco Corp.. It is a Class 1 Gastroenterology & Urology device (product code EYQ) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K841953 · Ipco Corp. · Gastroenterology & Urology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jul 1984

Decision

66d

Days

Class 1

Risk

K841953 is an FDA 510(k) clearance for the ULTRA SHIELD BRIEFS. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Ipco Corp. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1984 after a review of 66 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

Submission Details

510(k) Number	K841953 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 1984
Decision Date	July 19, 1984
Days to Decision	66 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

64d faster than avg

Panel avg: 130d · This submission: 66d

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 16

Devices cleared under the same product code (EYQ) and FDA review panel - the closest regulatory comparables to K841953.

ADULT DISPOS. INCONTINENT PANTS

K850153 · Convatec, A Division of E.R. Squibb & Sons · Feb 1985

DIGNITY PANT & ABSORBENT PADS

K850154 · Convatec, A Division of E.R. Squibb & Sons · Feb 1985

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

ADULT INCONTINET BRIEF

K821397 · Johnson & Johnson Professionals, Inc. · May 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K841953

Ipco Corp.

Mchenry, IL · US

Regulatory profile

23 submissions 23 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active