Cleared Traditional

ELECATH DUAL MODE TRANSTHORACIC PACING (K810312) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810312 · Electro-Catheter Corp. · Cardiovascular device
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Mar 1981
Decision
27d
Days
Class 2
Risk

K810312 is an FDA 510(k) clearance for the ELECATH DUAL MODE TRANSTHORACIC PACING. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight 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 Electro-Catheter Corp. devices

Submission Details

510(k) Number K810312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date March 04, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 50
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K810312.
USCI TRANSTHORACIC TEMP. PACING ELECTROD
K812307 · C.R. Bard, Inc. · Sep 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
K811318 · Medtronic Vascular · Jul 1981
TEMPTRON #'S 6804/6805
K810657 · Medtronic Vascular · Apr 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · Cordis Corp. · Feb 1981
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · C.R. Bard, Inc. · Apr 1980
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · Edwards Lifesciences, LLC · Jul 1979