Cleared Traditional

K851890 - MEDTRONIC 5064

K851890 is the FDA 510(k) clearance for MEDTRONIC 5064 by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K851890 · Medtronic Vascular · Cardiovascular device

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Jun 1985

Decision

50d

Days

Class 2

Risk

K851890 is an FDA 510(k) clearance for the MEDTRONIC 5064. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Medtronic Vascular devices

Submission Details

510(k) Number	K851890 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 1985
Decision Date	June 19, 1985
Days to Decision	50 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

75d faster than avg

Panel avg: 125d · This submission: 50d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DTD Pacemaker Lead Adaptor
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.3620

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 - DTD Pacemaker Lead Adaptor

All 84

Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K851890.

329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR

K852253 · Cordis Corp. · Jul 1985

MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD

K851457 · Intermedics, Inc. · Jul 1985

MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD

K851458 · Intermedics, Inc. · Jul 1985

PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE

K851665 · Pacesetter Systems · May 1985

PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD

K851145 · Pacesetter Systems · Apr 1985

PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD

K850652 · Pacesetter Systems · Apr 1985

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 K851890

Medtronic Vascular

Minneapolis, MN · US

EDWARD W NUMAINVILL

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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