Cleared Traditional

K932948 - MEDTRONIC MODEL 3625 SCREENER SYSTEM

K932948 is the FDA 510(k) clearance for MEDTRONIC MODEL 3625 SCREENER SYSTEM by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K932948 · Medtronic Vascular · Neurology device

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Optimized for regulatory review, auditing and printing

Feb 1994

Decision

231d

Days

Class 2

Risk

K932948 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3625 SCREENER SYSTEM. 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 3, 1994 after a review of 231 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	K932948 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 17, 1993
Decision Date	February 03, 1994
Days to Decision	231 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

83d slower than avg

Panel avg: 148d · This submission: 231d

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 74

Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K932948.

NEUROLOGICAL LEAD ACCESSORIES

K936099 · Medtronic Vascular · Jul 1994

TEMPORARY SCREENING LEAD/CATHETER KIT

K934938 · Medtronic Vascular · Jun 1994

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

K932202 · Medtronic Vascular · May 1994

MEDTRONIC MODEL 3487A PISCES-QUAD LEAD

K923931 · Medtronic Vascular · Mar 1993

MEDTRONIC MODEL 3080 PISCES-QUAD LEAD

K924522 · Medtronic Vascular · Mar 1993

MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD

K923567 · Medtronic Vascular · Nov 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 K932948

Medtronic Vascular

Minneapolis, MN · US

DAVID 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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