Cleared Traditional

K800326 - ARCOLITH 3021-CARDIAC PULSE GENERATOR

K800326 is an FDA 510(k) clearance for ARCOLITH 3021-CARDIAC PULSE GENERATOR, 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 34-day FDA review.

K800326 · Arco Medical Products Co. · Cardiovascular device
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Mar 1980
Decision
34d
Days
Class 3
Risk

K800326 is an FDA 510(k) clearance for the ARCOLITH 3021-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 March 17, 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

FDA 510(k) Submission Details - K800326

510(k) Number K800326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1980
Decision Date March 17, 1980
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 K800326.
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644 · Intermedics, Inc. · Apr 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-04
K800645 · Intermedics, Inc. · Apr 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573 · Telectronics, Inc. · Mar 1980
PULSE GENERATOR, MODEL NO. LIT 222
K792526 · Bentley Laboratories, Inc. · Feb 1980
SORIN PULSE GENERATOR MODEL # LIT 214 H
K792565 · Bentley Laboratories, Inc. · Feb 1980
MICROTHIN-DI
K800026 · Cardiac Pacemakers, Inc. · Jan 1980