Cleared Traditional

K834438 - TEMPERATURE SENSING FOLEY CATHETER

K834438 is an FDA 510(k) clearance for TEMPERATURE SENSING FOLEY 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 47-day FDA review.

K834438 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
47d
Days
Class 2
Risk

K834438 is an FDA 510(k) clearance for the TEMPERATURE SENSING FOLEY CATHETER. 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 February 4, 1984 after a review of 47 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.

FDA 510(k) Submission Details - K834438

510(k) Number K834438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date February 04, 1984
Days to Decision 47 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
84d faster than avg
Panel avg: 131d · This submission: 47d
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 234
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K834438.
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984
MMG FOLEY CATHETER
K840839 · Medical Technologies of Georgia · Apr 1984
FOLEY CATHETERIZATION TRAY-VARIOUS
K832363 · Inmed Corp. · Mar 1984
PREPACELL THIN NEEDLE ASPIRATION TRAY
K833719 · Applied Medical Devices, Inc. · Jan 1984
CATHETER INSERTION KIT
K833432 · Clinipad Corp. · Dec 1983
CURITY 100% SILICONE COUDE' CATHETER
K833790 · The Kendal Co. · Dec 1983
K834438 · TEMPERATURE SENSING FOLEY CATHETER
Download PDF C.R. Bard, Inc.