Cleared Traditional

K770814 - CATHETER, URETHERAL

K770814 is an FDA 510(k) clearance for CATHETER, 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 168-day FDA review.

K770814 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Oct 1977
Decision
168d
Days
Class 2
Risk

K770814 is an FDA 510(k) clearance for the CATHETER, URETHERAL. 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 October 18, 1977 after a review of 168 days - an extended review 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: 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 - K770814

510(k) Number K770814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1977
Decision Date October 18, 1977
Days to Decision 168 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
37d slower than avg
Panel avg: 131d · This submission: 168d
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 K770814.
UNIVERSAL FOLEY CATHETER TRAY
K791332 · Abco Dealers, Inc. · Aug 1979
STERILE 100% SILICONE FOLEY CATHETER
K780675 · Medline Industries, Inc. · May 1978
STERILE CLOSED SYSTEM
K780676 · Medline Industries, Inc. · May 1978
CATHETERIZATION SYS. URINARY DRAINAGE
K771779 · Medical Devices, Inc. · Oct 1977
CATHETER WITH HARD VALVE
K770489 · Pharmaseal Div., Baxter Healthcare Corp. · Mar 1977
TRAVACATH
K770493 · Travenol Laboratories, S.A. · Mar 1977