Cleared Traditional

MEDTRONIC MODEL 3080 PISCES-QUAD LEAD (K924522) - FDA 510(k) Clearance

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

K924522 · Medtronic Vascular · Neurology device

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Mar 1993

Decision

191d

Days

Class 2

Risk

K924522 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3080 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 March 18, 1993 after a review of 191 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number	K924522 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1992
Decision Date	March 18, 1993
Days to Decision	191 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

43d slower than avg

Panel avg: 148d · This submission: 191d

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 K924522.

MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT

K932202 · Medtronic Vascular · May 1994

MEDTRONIC MODEL 3625 SCREENER SYSTEM

K932948 · Medtronic Vascular · Feb 1994

MEDTRONIC MODEL 3487A PISCES-QUAD LEAD

K923931 · Medtronic Vascular · Mar 1993

MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD

K923567 · Medtronic Vascular · Nov 1992

MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS

K921558 · Medtronic Vascular · Jul 1992

MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS

K913993 · Medtronic Vascular · Feb 1992

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 K924522

Medtronic Vascular

Minneapolis, MN · US

DAVID H MUELLER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

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

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