Cleared Traditional

COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER (K853651) - FDA 510(k) Clearance

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

K853651 · Cook Pacemaker Corp. · Cardiovascular device
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Oct 1985
Decision
50d
Days
Class 3
Risk

K853651 is an FDA 510(k) clearance for the COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER. 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 October 23, 1985 after a review of 50 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 K853651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date October 23, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
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 K853651.
SUPRIMA MODEL 254-24
K852340 · Intermedics, Inc. · Nov 1985
MEDTRONICS MODELS 8320/8322/8329
K852688 · Medtronic Vascular · Nov 1985
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
K852748 · Cordis Corp. · Nov 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034 · Intermedics, Inc. · Jul 1985
SUPRIMA II MODEL 254-26
K852431 · Intermedics, Inc. · Jul 1985
SUPRIMA II MODEL 253-23
K852430 · Intermedics, Inc. · Jul 1985