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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all C.R. Bard, Inc. devices

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 70
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K862631.
SmartBag (SmartPouch)
K181643 · 11 Health Technologies Limited · Nov 2018
OSTOM-I ALERT
K140938 · 11 Health and Technologies, LLC · Oct 2014
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636 · Coloplast A/S · Jul 1988
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