Cleared Special

MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD (K012454) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012454 · Medtronic Vascular · Cardiovascular device

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Aug 2001

Decision

13d

Days

Class 2

Risk

K012454 is an FDA 510(k) clearance for the MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Vascular devices

Submission Details

510(k) Number	K012454 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 01, 2001
Decision Date	August 14, 2001
Days to Decision	13 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

112d faster than avg

Panel avg: 125d · This submission: 13d

Pathway characteristics

Modification to existing cleared device.

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 46

Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K012454.

DETECT SURGICAL PACING AND MAPPING TOOL

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STEELEX ELECTRODE SET

K030556 · Aesculap, Inc. · Apr 2003

MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD

K012452 · Medtronic Vascular · Aug 2001

MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

K012458 · Medtronic Vascular · Aug 2001

MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE

K012459 · Medtronic Vascular · Aug 2001

MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD

K012460 · Medtronic Vascular · Aug 2001

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K012454

Medtronic Vascular

Minneapolis, MN · US

TINA BENOIT

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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