Cleared Traditional

K861368 - MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR

K861368 is an FDA 510(k) clearance for MEDTRONIC MODEL 5328 PROGRAMMABLE STIMU..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K861368 · Medtronic Vascular · Cardiovascular device
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Aug 1986
Decision
115d
Days
Class 2
Risk

K861368 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 4, 1986 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K861368

510(k) Number K861368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1986
Decision Date August 04, 1986
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOQ Device Classification - Class 2, Special Controls

Product Code JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1750
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 - JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

All 9
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K861368.
EP-4 CLINICAL STIMUTATOR
K041442 · Ep Medsystems · Sep 2004
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
K991293 · Fischer Medical Technologies, Inc. · May 2000
PACE-1A CARDIAC STIMULATOR
K963579 · Radionics, Inc. · Nov 1996
EXTERNAL PACEMAKER TELECTRONICS TE200
K852746 · Seamed Corp. · Sep 1985
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · Cordis Corp. · Jun 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · Medtronic Vascular · Apr 1985