Cleared Traditional

K801324 - SIEMENS-ELEMA PULSE GENERATOR 668 (FDA 510(k) Clearance)

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

K801324 · Siemens Elema AB · Cardiovascular device
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Dec 1980
Decision
181d
Days
Class 3
Risk

K801324 is an FDA 510(k) clearance for the SIEMENS-ELEMA PULSE GENERATOR 668. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Siemens Elema AB (Walker, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 181 days - an extended review 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 Siemens Elema AB devices

Submission Details

510(k) Number K801324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date December 01, 1980
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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.