Cleared Traditional

K874154 - ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

K874154 is an FDA 510(k) clearance for ELECATH TRANSESOPHAGEAL PACING CATHETER, manufactured by Electro-Catheter Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K874154 · Electro-Catheter Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
199d
Days
Class 2
Risk

K874154 is an FDA 510(k) clearance for the ELECATH(R) TRANSESOPHAGEAL PACING CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Rahway, US). The FDA issued a Cleared decision on April 29, 1988 after a review of 199 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Electro-Catheter Corp. devices

FDA 510(k) Submission Details - K874154

510(k) Number K874154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date April 29, 1988
Days to Decision 199 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
68d slower than avg
Panel avg: 131d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 406
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K874154.
COMPAT (R) ENTERAL DELIVERY SYSTEM
K882218 · Sandoz Nutrition · Sep 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · Medical Innovations Corp. · Aug 1988
DENT SLEEVE MANOMETRIC CATHETER
K881310 · Wilson-Cook Medical, Inc. · May 1988
MIC (SPECIFIC LINE) REPLACEMENT KIT
K880768 · Medical Innovations Corp. · Apr 1988
MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K874936 · Medsurg Industries, Inc. · Apr 1988
ENTERAL BAG/SET
K880051 · Churchill Corp. · Apr 1988