Cleared Traditional

K823559 - AFP PULSE GENERATOR

K823559 is the FDA 510(k) clearance for AFP PULSE GENERATOR by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K823559 · Pacesetter Systems · Cardiovascular device
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Feb 1983
Decision
78d
Days
Class 3
Risk

K823559 is an FDA 510(k) clearance for the AFP PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983 after a review of 78 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 K823559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1982
Decision Date February 18, 1983
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 K823559.
MEDTRONIC MODELS 59401 5941
K823831 · Medtronic Vascular · Mar 1983
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC
K823863 · Intermedics, Inc. · Mar 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · Pacesetter Systems · Feb 1983
TELEMETRY DECODER #540-02
K823678 · Intermedics, Inc. · Dec 1982
KALOS-03 BIPOLAR
K822907 · Biotronik Sales, Inc. · Nov 1982
MODEL 325D UNIPOLAR CARDIAC PULSE GEN
K822904 · Cook Pacemaker Corp. · Oct 1982