Cleared Traditional

ARCOLITH 2100-CARDIAC PULSE GENERATOR (K792216) - FDA 510(k) Clearance

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

K792216 · Arco Medical Products Co. · Cardiovascular device
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Nov 1979
Decision
24d
Days
Class 3
Risk

K792216 is an FDA 510(k) clearance for the ARCOLITH 2100-CARDIAC PULSE GENERATOR. 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 November 29, 1979 after a review of 24 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 K792216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1979
Decision Date November 29, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
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 K792216.
MODEL 253-11 CYBERLITH PULSE GENERATOR
K800895 · Intermedics, Inc. · Apr 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644 · Intermedics, Inc. · Apr 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645 · Intermedics, Inc. · Apr 1980
MEDTRONIC MODELS 5984/5985
K791316 · Medtronic Vascular · Nov 1979
OMNI-STANICOR (THETA) MOD 237A
K791783 · Cordis Corp. · Oct 1979
PULSE GENERATORS, MODELS 5983, 5989
K790068 · Medtronic Vascular · Sep 1979