Cleared Traditional

K862631 - BARD IRYFIX(TM) STOMA CAP

K862631 is an FDA 510(k) clearance for BARD IRYFIX(TM) STOMA CAP, manufactured by C.R. Bard, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K862631 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
98d
Days
Class 1
Risk

K862631 is an FDA 510(k) clearance for the BARD IRYFIX(TM) STOMA CAP. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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.

FDA 510(k) Submission Details - K862631

510(k) Number K862631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1986
Decision Date October 16, 1986
Days to Decision 98 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
33d faster than avg
Panel avg: 131d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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 - EXB Collector, Ostomy

All 99
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K862631.
EZ TAC FILTER
K870531 · John F. Greer Co., Inc. · Apr 1987
PERSONAL PUNCH
K870136 · Arnold Technologies · Apr 1987
ULTRA-GEL - #4083
K864189 · John F. Greer Co., Inc. · Dec 1986
COLOPLAST CONVEX RING
K861070 · Coloplast A/S · Jun 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · Convatec, A Division of E.R. Squibb & Sons · Apr 1986
MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
K854726 · Pfizer, Inc. · Feb 1986
K862631 · BARD IRYFIX(TM) STOMA CAP
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