Cleared Traditional

K852688 - MEDTRONICS MODELS 8320/8322/8329

K852688 is the FDA 510(k) clearance for MEDTRONICS MODELS 8320/8322/8329 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K852688 · Medtronic Vascular · Cardiovascular device
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Nov 1985
Decision
129d
Days
Class 3
Risk

K852688 is an FDA 510(k) clearance for the MEDTRONICS MODELS 8320/8322/8329. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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

Submission Details

510(k) Number K852688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1985
Decision Date November 01, 1985
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K852688.
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
K854214 · Cordis Corp. · Dec 1985
SUPRIMA MODEL 254-22
K852339 · Intermedics, Inc. · Nov 1985
SUPRIMA MODEL 254-24
K852340 · Intermedics, Inc. · Nov 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748 · Cordis Corp. · Nov 1985
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
K854143 · Telectronics, Inc. · Nov 1985
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K853590 · Cook Pacemaker Corp. · Oct 1985