Cleared Traditional

K852276 - ESTEEM INCONTINENT SYSTEM

K852276 is an FDA 510(k) clearance for ESTEEM INCONTINENT SYSTEM, manufactured by Bevan Medical, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K852276 · Bevan Medical, Inc. · Gastroenterology & Urology device
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Aug 1985
Decision
70d
Days
Class 1
Risk

K852276 is an FDA 510(k) clearance for the ESTEEM INCONTINENT SYSTEM. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Bevan Medical, Inc. (Rexdale, CA). The FDA issued a Cleared decision on August 7, 1985 after a review of 70 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 Bevan Medical, Inc. devices

FDA 510(k) Submission Details - K852276

510(k) Number K852276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date August 07, 1985
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
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 K852276.
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
ATTENDS INCONTINENT UNDERGARMENT
K850611 · Procter & Gamble Mfg. Co. · Feb 1985
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