Cleared Traditional

K821272 - BN-74 COATED BARDEX ALL SILICONE CATH

K821272 is an FDA 510(k) clearance for BN-74 COATED BARDEX ALL SILICONE CATH, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K821272 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jun 1982
Decision
50d
Days
Class 2
Risk

K821272 is an FDA 510(k) clearance for the BN-74 COATED BARDEX ALL SILICONE CATH. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1982 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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

FDA 510(k) Submission Details - K821272

510(k) Number K821272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date June 22, 1982
Days to Decision 50 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
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOD Catheter, Urological

All 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K821272.
RETRIEVAL BALLOONS
K821818 · American Endoscopy, Inc. · Sep 1982
DYNACOR URETHRAL CATHETER TRAY
K821970 · Medline Industries, Inc. · Jul 1982
BARDEX ALL SILICONE PEDIATRIC CATHETER
K821745 · C.R. Bard, Inc. · Jun 1982
FOLEY INSERTION TRAYS W/OVERWRAY
K820987 · Inmed Corp. · May 1982
CURITY ECONOMY I CYSTOSCOPY
K820838 · The Kendal Co. · May 1982
URETERAL CATHETER CONNECTING TUBE
K820866 · Van-Tec, Inc. · Apr 1982