Cleared Traditional

K862298 - ALTERNATE SIZE E-Z-PACE ELECTRODE

K862298 is an FDA 510(k) clearance for ALTERNATE SIZE E-Z-PACE ELECTRODE, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K862298 · Medtronic Vascular · Cardiovascular device
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Jul 1986
Decision
24d
Days
Class 2
Risk

K862298 is an FDA 510(k) clearance for the ALTERNATE SIZE E-Z-PACE ELECTRODE. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Medtronic Vascular (Lawrence, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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.

FDA 510(k) Submission Details - K862298

510(k) Number K862298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date July 11, 1986
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 83
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K862298.
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
K864988 · Medac, Inc. · Mar 1987
ETP 180A NON-INVASIVE EXTERNAL PACEMAKER
K864989 · Medac, Inc. · Mar 1987
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE
K863547 · Medtronic Vascular · Oct 1986
DCI MODEL EP-2 CLINICAL STIMULATOR
K854196 · Digital Cardiovascular Instruments, Inc. · May 1986
ETP 180 CARDIAC PACEMAKER (EXTERNAL)
K860551 · Biotronics Corp. · Apr 1986
NONINVASIVE TEMP. PACEMAKER NTP-1000
K855015 · Zmi Corp. · Mar 1986
K862298 · ALTERNATE SIZE E-Z-PACE ELECTRODE
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