Cleared Traditional

K850651 - PROGRAMALITH III-3 MODEL 231 PULSE GENE...

K850651 is the FDA 510(k) clearance for PROGRAMALITH III-3 MODEL 231 PULSE GENE... by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K850651 · Pacesetter Systems · Cardiovascular device
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Apr 1985
Decision
41d
Days
Class 3
Risk

K850651 is an FDA 510(k) clearance for the PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR. 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 April 1, 1985 after a review of 41 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 Pacesetter Systems devices

Submission Details

510(k) Number K850651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date April 01, 1985
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 K850651.
NEOS-LP PULSE GENERATOR
K844842 · Biotronik Sales, Inc. · Apr 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252 · Telectronics, Inc. · Apr 1985
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
K851081 · Telectronics, Inc. · Apr 1985
EKG TRANSMITTER MODEL 5134
K842051 · Instromedix, Inc. · Mar 1985
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
K850656 · Cook Pacemaker Corp. · Mar 1985
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
K844793 · Intermedics, Inc. · Feb 1985