Cleared Traditional

COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM (K850656) - FDA 510(k) Clearance

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

K850656 · Cook Pacemaker Corp. · Cardiovascular device
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Mar 1985
Decision
10d
Days
Class 3
Risk

K850656 is an FDA 510(k) clearance for the COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 10 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 Cook Pacemaker Corp. devices

Submission Details

510(k) Number K850656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date March 01, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K850656.
MULTICOR GAMMA MODELS 336/337
K851417 · Cordis Corp. · Jun 1985
OMNI-ATRICOR MODEL 308A
K851418 · Cordis Corp. · Jun 1985
MULTICOR GAMMA 402 SERIES PACER
K851419 · Cordis Corp. · Jun 1985
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
K844793 · Intermedics, Inc. · Feb 1985
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957 · Medtronic Vascular · Feb 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · Medtronic Vascular · Feb 1985