Cleared Traditional

K771987 - MICROPULSE 26U PULSE GENERATOR

K771987 is an FDA 510(k) clearance for MICROPULSE 26U PULSE 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 14-day FDA review.

K771987 · Edwards Pacemaker Systems · Cardiovascular device
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Nov 1977
Decision
14d
Days
Class 3
Risk

K771987 is an FDA 510(k) clearance for the MICROPULSE 26U PULSE GENERATOR. 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 November 2, 1977 after a review of 14 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 - K771987

510(k) Number K771987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1977
Decision Date November 02, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
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 K771987.
CARDIAC PACEMAKER C2001
K772010 · Vitatron Medical BV · Nov 1977
CARDIAC PULSE GENERATOR, MODEL 150L
K772026 · Telectronics, Inc. · Nov 1977
BIPOLAR PACEMAKER MODEL 224
K772057 · Intermedics, Inc. · Nov 1977
PACEMAKER MODEL 251
K771626 · Intermedics, Inc. · Sep 1977
IMPLANTED PACEMAKER PLUSE GENERATOR
K771670 · Telectronics, Inc. · Sep 1977
PACEMAKER & CARDIAC LEAD, BIPOLAR
K771262 · Arco Medical Products Co. · Jul 1977