Cleared Traditional

K770716 - GENERATOR

K770716 is the FDA 510(k) clearance for GENERATOR by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K770716 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Apr 1977
Decision
8d
Days
Class 3
Risk

K770716 is an FDA 510(k) clearance for the GENERATOR, PULSE, UNIPOLAR, MODEL #504. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1977 after a review of 8 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K770716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1977
Decision Date April 26, 1977
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 280
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K770716.
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, BIPOLAR, MODEL #604
K770715 · Cardiac Pacemakers, Inc. · Apr 1977
CENTURION
K770419 · Johnson & Johnson Professionals, Inc. · Apr 1977
UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR
K770197 · Cardiac Pacemakers, Inc. · Feb 1977