Cleared Traditional

K791165 - ARCOLITH 4000

K791165 is an FDA 510(k) clearance for ARCOLITH 4000, manufactured by Arco Medical Products Co.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K791165 · Arco Medical Products Co. · Cardiovascular device
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Jul 1979
Decision
15d
Days
Class 3
Risk

K791165 is an FDA 510(k) clearance for the ARCOLITH 4000. 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 July 10, 1979 after a review of 15 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

FDA 510(k) Submission Details - K791165

510(k) Number K791165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date July 10, 1979
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 388
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791165.
UNILITH PULSE GENERATOR
K791219 · Ela Medical, Inc. · Jul 1979
PULSE GENERATOR, MODEL 171
K782161 · Telectronics, Inc. · Jul 1979
BATTERY CHARGER, 171 PACEMAKER
K782162 · Telectronics, Inc. · Jul 1979
MODELS 2411/2418 VENTRICULAR-INHIBITED
K791093 · Medtronic Vascular · Jun 1979
VITALITH S 3000 SERIES
K790666 · Vitatron Medical BV · Jun 1979
CARDIAC PULSE GENERATOR, 16 SERIES
K790867 · Telectronics, Inc. · May 1979