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
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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.

View all C.R. Bard, Inc. devices

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 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K834438.
UROLOGICAL CATHETER & ACCESSORIES
K841727 · Research Medical, Inc. · Jun 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984
FOLEY CATHETERIZATION TRAY-VARIOUS
K832363 · Inmed Corp. · Mar 1984
CURITY 100% SILICONE COUDE' CATHETER
K833790 · The Kendal Co. · Dec 1983
CATHETER CARE TRAY
K832389 · Inmed Corp. · Sep 1983
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · Electromedics, Inc. · Sep 1983