Cleared Traditional

K821003 - PROGRAMMALITH II

K821003 is the FDA 510(k) clearance for PROGRAMMALITH II by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K821003 · Pacesetter Systems · Cardiovascular device
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May 1982
Decision
28d
Days
Class 3
Risk

K821003 is an FDA 510(k) clearance for the PROGRAMMALITH II, #225 & 226. 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 May 7, 1982 after a review of 28 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 K821003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1982
Decision Date May 07, 1982
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K821003.
COMMAND NP
K822309 · Cardiac Pacemakers, Inc. · Oct 1982
JAIN INSULATING BOOT MODEL 225B
K822652 · Cook Pacemaker Corp. · Oct 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147 · Medtronic Vascular · Aug 1982
PULSE GENERATOR
K821073 · Biotronik Sales, Inc. · May 1982
COOK #326T PROGRAM/TELEMETRY BIPOLAR
K821147 · Cook Pacemaker Corp. · May 1982
PULSE GENERATOR 678 B
K820657 · Siemens Elema AB · Apr 1982