Cleared Traditional

K834575 - BARD KARAYA GUM WASHERS

K834575 is the FDA 510(k) clearance for BARD KARAYA GUM WASHERS by C.R. Bard, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K834575 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
37d
Days
Class 1
Risk

K834575 is an FDA 510(k) clearance for the BARD KARAYA GUM WASHERS. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 37 days - a notably fast clearance cycle.

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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K834575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date February 04, 1984
Days to Decision 37 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
93d faster than avg
Panel avg: 130d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 55
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K834575.
MC 2002 OSTOMY POUCHES & SKIN FLANGES
K840265 · Coloplast A/S · Apr 1984
FILTRODER FILTERS
K840267 · Coloplast A/S · Apr 1984
MC 2000 OSTOMY POUCHES
K840269 · Coloplast A/S · Apr 1984
SUR-FIT UROSTOMY POUCH W/ACCUSEAL
K840166 · Convatec, A Division of E.R. Squibb & Sons · Feb 1984
COMFEEL PASTE
K833565 · Coloplast A/S · Jan 1984
STERILE DRAINAGE SYSTEM
K833571 · Coloplast A/S · Jan 1984