Cleared Traditional

K813576 - SIEMENS-ELEMA PULSE GENERATOR 659

K813576 is an FDA 510(k) clearance for SIEMENS-ELEMA PULSE GENERATOR 659, 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 30-day FDA review.

K813576 · Siemens Elema AB · Cardiovascular device
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Jan 1982
Decision
30d
Days
Class 3
Risk

K813576 is an FDA 510(k) clearance for the SIEMENS-ELEMA PULSE GENERATOR 659. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982 after a review of 30 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K813576

510(k) Number K813576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1981
Decision Date January 22, 1982
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K813576.
COMMAND ULTRA I
K820231 · Cardiac Pacemakers, Inc. · Mar 1982
MEDICAL MULTILITH PULSE GENERA-1140
K813246 · Ela Medical, Inc. · Feb 1982
COMMAND P5
K813534 · Cardiac Pacemakers, Inc. · Jan 1982
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610 · Siemens Corp. · Dec 1981
BIPOLAR OPTIMA MP #255
K813079 · Telectronics, Inc. · Dec 1981
DIRECTIONAL BOOT
K813150 · Pacesetter Systems · Dec 1981