Cleared Traditional

K790873 - MODEL 221 PROGRAMALITH PULSE GENERATOR

K790873 is the FDA 510(k) clearance for MODEL 221 PROGRAMALITH PULSE GENERATOR by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K790873 · Pacesetter Systems · Cardiovascular device
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Sep 1979
Decision
136d
Days
Class 3
Risk

K790873 is an FDA 510(k) clearance for the MODEL 221 PROGRAMALITH 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 September 20, 1979 after a review of 136 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 K790873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date September 20, 1979
Days to Decision 136 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
11d slower than avg
Panel avg: 125d · This submission: 136d
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 K790873.
PULSE GENERATORS, MODELS 5983, 5989
K790068 · Medtronic Vascular · Sep 1979
CORDIS BIPOLAR PACER CONNECTOR SYSTEM
K791784 · Cordis Corp. · Sep 1979
IMPLANTABLE VENTRICULAR-INHIBITED
K791727 · Telectronics, Inc. · Sep 1979
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K791181 · Medtronic Vascular · Sep 1979
IMPLANTABLE PULSE GENERATOR PACEMAKERS
K791568 · Intermedics, Inc. · Sep 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379 · Intermedics, Inc. · Sep 1979