Cleared Traditional

K801324 - SIEMENS-ELEMA PULSE GENERATOR 668

K801324 is an FDA 510(k) clearance for SIEMENS-ELEMA PULSE GENERATOR 668, manufactured by Siemens Elema AB. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K801324 · Siemens Elema AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K801324

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K801324.
MICRO THIN-PII, #0523
K802353 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-DI BIPOLAR PULSE GENERATOR
K802409 · Cardiac Pacemakers, Inc. · Oct 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · Cardiac Pacemakers, Inc. · Oct 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · Bentley Laboratories, Inc. · Oct 1980