Cleared Traditional

K832052 - MODEL 327T UNIPOLAR CARDIAC PULSE GEN

K832052 is an FDA 510(k) clearance for MODEL 327T UNIPOLAR CARDIAC PULSE GEN, manufactured by Cook Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K832052 · Cook Pacemaker Corp. · Cardiovascular device
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Aug 1983
Decision
42d
Days
Class 3
Risk

K832052 is an FDA 510(k) clearance for the MODEL 327T UNIPOLAR CARDIAC PULSE GEN. 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 August 8, 1983 after a review of 42 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

FDA 510(k) Submission Details - K832052

510(k) Number K832052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date August 08, 1983
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K832052.
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633 · Intermedics, Inc. · Oct 1983
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI
K832893 · Cook Pacemaker Corp. · Oct 1983
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
K831771 · Telectronics, Inc. · Aug 1983
COMMAND ULTRA II
K831216 · Cardiac Pacemakers, Inc. · Jul 1983
COMMAND ULTRA I
K831161 · Cardiac Pacemakers, Inc. · Jun 1983
NEDS-01 & EPR-500
K830862 · Biotronik Sales, Inc. · May 1983