Cleared Traditional

K872779 - PROLOG MP PULSE GENERATORS 658K AND 658T

K872779 is the FDA 510(k) clearance for PROLOG MP PULSE GENERATORS 658K AND 658T by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K872779 · Pacesetter Systems · Cardiovascular device
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Nov 1987
Decision
113d
Days
Class 3
Risk

K872779 is an FDA 510(k) clearance for the PROLOG MP PULSE GENERATORS 658K AND 658T. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 113 days - within the typical 510(k) review window.

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 Pacesetter Systems devices

Submission Details

510(k) Number K872779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1987
Decision Date November 04, 1987
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K872779.
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · Telectronics, Inc. · Jul 1988
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · Intermedics, Inc. · Nov 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · Telectronics, Inc. · Nov 1987
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
K873528 · Intermedics, Inc. · Oct 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · Telectronics, Inc. · Aug 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · Medtronic Vascular · Aug 1987