Cleared Traditional

K790452 - 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS

K790452 is an FDA 510(k) clearance for 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS, manufactured by Edwards Pacemaker Systems. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K790452 · Edwards Pacemaker Systems · Cardiovascular device
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May 1979
Decision
64d
Days
Class 3
Risk

K790452 is an FDA 510(k) clearance for the 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Edwards Pacemaker Systems (Mchenry, US). The FDA issued a Cleared decision on May 8, 1979 after a review of 64 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 Edwards Pacemaker Systems devices

FDA 510(k) Submission Details - K790452

510(k) Number K790452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date May 08, 1979
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
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 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K790452.
CARDIAC PULSE GENERATOR, 16 SERIES
K790867 · Telectronics, Inc. · May 1979
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868 · Telectronics, Inc. · May 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · Cordis Corp. · May 1979
PULSE GENERATOR MODEL 61 AND 128
K790562 · Ela Medical, Inc. · May 1979
PACEMAKERS WITHOUT SILASTIC COATING
K790764 · Telectronics, Inc. · Apr 1979
MICROLITH MODELS 505
K790432 · Cardiac Pacemakers, Inc. · Mar 1979