Cleared Traditional

UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (K801241) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K801241 · Arco Medical Products Co. · Cardiovascular device
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Jun 1980
Decision
34d
Days
Class 3
Risk

K801241 is an FDA 510(k) clearance for the UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Arco Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 34 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 Arco Medical Products Co. devices

Submission Details

510(k) Number K801241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1980
Decision Date June 30, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K801241.
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · Intermedics, Inc. · Sep 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450 · Intermedics, Inc. · Aug 1980
MULTICOR (GAMMA) MODEL 336 & MODEL 337
K801106 · Cordis Corp. · Jul 1980
MEDTRONIC MODELS 5966/5967, ETC.
K800069 · Medtronic Vascular · Jun 1980
MODEL 5985 PACEMAKER PULSE GENERATOR
K800285 · Medtronic Vascular · May 1980
MODEL 253-11 CYBERLITH PULSE GENERATOR
K800895 · Intermedics, Inc. · Apr 1980