Cleared Traditional

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE (K854214) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K854214 · Cordis Corp. · Cardiovascular device
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Dec 1985
Decision
47d
Days
Class 3
Risk

K854214 is an FDA 510(k) clearance for the MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 47 days - a notably fast clearance cycle.

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 Cordis Corp. devices

Submission Details

510(k) Number K854214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1985
Decision Date December 03, 1985
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 181
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K854214.
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
K854482 · Medtronic Vascular · Feb 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · Cordis Corp. · Jan 1986
SUPRIMA MODEL 254-22
K852339 · Intermedics, Inc. · Nov 1985
SUPRIMA MODEL 254-24
K852340 · Intermedics, Inc. · Nov 1985
MEDTRONICS MODELS 8320/8322/8329
K852688 · Medtronic Vascular · Nov 1985