Cleared Traditional

K802259 - TRANSVENOUS PACEMAKER ELECTRODE KIT

K802259 is an FDA 510(k) clearance for TRANSVENOUS PACEMAKER ELECTRODE KIT, manufactured by Stanco Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K802259 · Stanco Medical, Inc. · Cardiovascular device
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Oct 1980
Decision
37d
Days
Class 2
Risk

K802259 is an FDA 510(k) clearance for the TRANSVENOUS PACEMAKER ELECTRODE KIT. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 37 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 Stanco Medical, Inc. devices

FDA 510(k) Submission Details - K802259

510(k) Number K802259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date October 23, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K802259.
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312 · Electro-Catheter Corp. · Mar 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · Cordis Corp. · Feb 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
K803058 · American Edwards Laboratories · Jan 1981
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · C.R. Bard, Inc. · Apr 1980
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · Edwards Lifesciences, LLC · Jul 1979
TEMPORARY CARDIAC PACING WIRE
K781002 · Ethicon, Inc. · Dec 1978