Cleared Traditional

COOK PACEMAKER 215 UNIPOLAR CARDIAC- (K841928) - FDA 510(k) Clearance

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

K841928 · Cook Pacemaker Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
62d
Days
Class 3
Risk

K841928 is an FDA 510(k) clearance for the COOK PACEMAKER 215 UNIPOLAR CARDIAC-. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984 after a review of 62 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 K841928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1984
Decision Date July 11, 1984
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K841928.
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · Medtronic Vascular · Feb 1985
MEDTRONIC 5984-5984LP-5985
K843837 · Medtronic Vascular · Oct 1984
MEDTRONIC 8437/8438
K843089 · Medtronic Vascular · Aug 1984
PRIMA 236-02 NONPROGRAMMABLE CARDIAC
K841404 · Intermedics, Inc. · May 1984
QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE
K841073 · Intermedics, Inc. · May 1984
CARDIAC PULSE GENERATOR 254-18
K841074 · Intermedics, Inc. · May 1984