Cleared Traditional

K820988 - MEDTRONIC #1992-2 DUAL RATE TRANSMITTER

K820988 is the FDA 510(k) clearance for MEDTRONIC #1992-2 DUAL RATE TRANSMITTER by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K820988 · Medtronic Vascular · Neurology device

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Jun 1982

Decision

77d

Days

Class 2

Risk

K820988 is an FDA 510(k) clearance for the MEDTRONIC #1992-2 DUAL RATE TRANSMITTER. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on June 23, 1982 after a review of 77 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	K820988 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 1982
Decision Date	June 23, 1982
Days to Decision	77 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

71d faster than avg

Panel avg: 148d · This submission: 77d

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 K820988.

SPINAL CORD STIMULATION SYS SE-4

K833990 · Medtronic Vascular · Mar 1984

PISCES #3487 EPIDURAL LEAD FOR SPINAL

K831746 · Medtronic Vascular · Aug 1983

STIMUCORD EXTERNAL NEURAL STIM. 911A

K823530 · Cordis Corp. · Dec 1982

MEDTRONIC DUAL CHANNEL SPINAL CORD STIM

K812155 · Medtronic Vascular · Oct 1981

MEDTRONIC #3484 PISCES EPIDURAL LEAD

K812154 · Medtronic Vascular · Aug 1981

MYELOSTAT DORSAL CORD STIMULATOR

K811655 · Medtronic Vascular · Jul 1981

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 K820988

Medtronic Vascular

Walker, MI · US

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

Data Intelligence Layer

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

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