Cleared Traditional

K801978 - PROGRAMALITH #'S 221

K801978 is the FDA 510(k) clearance for PROGRAMALITH #'S 221 by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K801978 · Pacesetter Systems · Cardiovascular device
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Sep 1980
Decision
38d
Days
Class 3
Risk

K801978 is an FDA 510(k) clearance for the PROGRAMALITH #'S 221, 222, 221A & 222A. 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 26, 1980 after a review of 38 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 K801978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date September 26, 1980
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K801978.
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409 · Cardiac Pacemakers, Inc. · Oct 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · Cardiac Pacemakers, Inc. · Oct 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · Bentley Laboratories, Inc. · Oct 1980
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · Telectronics, Inc. · Sep 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793 · Telectronics, Inc. · Sep 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508 · Siemens Elema AB · Sep 1980