Cleared Traditional

MEDTRONIC MODEL 3487A PISCES-QUAD LEAD (K910199) - FDA 510(k) Clearance

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

K910199 · Medtronic Vascular · Neurology device

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Feb 1991

Decision

26d

Days

Class 2

Risk

K910199 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3487A PISCES-QUAD LEAD. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology device 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	K910199 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 16, 1991
Decision Date	February 11, 1991
Days to Decision	26 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

122d faster than avg

Panel avg: 148d · This submission: 26d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 882.5880

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 Neurology devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 70

Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K910199.

MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT

K912764 · Medtronic Vascular · Nov 1991

MEDTRONIC 3625 SCREENER SYSTEM

K913442 · Medtronic Vascular · Nov 1991

MEDTRONIC (R) MODEL 3625 SCREENER

K903690 · Medtronic Vascular · Feb 1991

MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME

K905407 · Medtronic Vascular · Feb 1991

MODEL 3586 RESUME LEAD

K890061 · Medtronic Vascular · Apr 1990

MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION

K892884 · Medtronic Vascular · Aug 1989

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 K910199

Medtronic Vascular

Minneapolis, MN · US

LINDA S ALEXANDER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

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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