Cleared Traditional

K770657 - GENERATOR, PULSE, CARDIAC 2LU

K770657 is an FDA 510(k) clearance for GENERATOR, 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 19-day FDA review.

K770657 · Edwards Pacemaker Systems · Cardiovascular device
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Apr 1977
Decision
19d
Days
Class 3
Risk

K770657 is an FDA 510(k) clearance for the GENERATOR, PULSE, CARDIAC 2LU. 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 April 26, 1977 after a review of 19 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 - K770657

510(k) Number K770657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1977
Decision Date April 26, 1977
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
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 K770657.
GENERATOR, PULSE, UNIPOLAR, #508
K770880 · Cardiac Pacemakers, Inc. · Jun 1977
GENERATOR, PULSE, BIPOLAR 3608
K770881 · Cardiac Pacemakers, Inc. · Jun 1977
CARDIAC PACERS W/NARROW PULSE WIDTH
K770951 · Cordis Corp. · Jun 1977
GENERATOR, PULSE, UNIPOLAR, MODEL #504
K770716 · Cardiac Pacemakers, Inc. · Apr 1977
GENERATOR, PULSE, BIPOLAR, MODEL #604
K770715 · Cardiac Pacemakers, Inc. · Apr 1977
CENTURION
K770419 · Johnson & Johnson Professionals, Inc. · Apr 1977