Cleared Traditional

K882418 - DRY COMFORT UNDERGARMENT

K882418 is an FDA 510(k) clearance for DRY COMFORT UNDERGARMENT, manufactured by Health Tec, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K882418 · Health Tec, Inc. · Gastroenterology & Urology device
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Sep 1988
Decision
108d
Days
Class 1
Risk

K882418 is an FDA 510(k) clearance for the DRY COMFORT UNDERGARMENT. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Health Tec, Inc. (Palmer, US). The FDA issued a Cleared decision on September 29, 1988 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Health Tec, Inc. devices

FDA 510(k) Submission Details - K882418

510(k) Number K882418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1988
Decision Date September 29, 1988
Days to Decision 108 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
22d faster than avg
Panel avg: 130d · This submission: 108d
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 16
Devices cleared under the same product code (EYQ) and FDA review panel - the closest regulatory comparables to K882418.
ATTENDS INCONTINENT BRIEF
K873036 · Procter & Gamble Mfg. Co. · Jan 1988
MALE URINARY STRESS PAD*
K862877 · Convatec, A Division of E.R. Squibb & Sons · Nov 1986
FREE & ACTIVE(TM) ABSORBENT PADS
K862878 · Convatec, A Division of E.R. Squibb & Sons · Nov 1986
MODIFIED PROTECTIVE GARMENT
K861863 · Procter & Gamble Mfg. Co. · Aug 1986
MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
K860598 · Procter & Gamble Mfg. Co. · Mar 1986
DEPEND FITTED BRIEF
K854378 · Kimberly-Clark Corp. · Dec 1985