Cleared Traditional

K841228 - PULSE GENERATOR 718B & 718L

K841228 is an FDA 510(k) clearance for PULSE GENERATOR 718B & 718L, 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 96-day FDA review.

K841228 · Siemens Elema AB · Cardiovascular device
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Jun 1984
Decision
96d
Days
Class 3
Risk

K841228 is an FDA 510(k) clearance for the PULSE GENERATOR 718B & 718L. 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 June 26, 1984 after a review of 96 days - within the typical 510(k) review window.

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 - K841228

510(k) Number K841228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1984
Decision Date June 26, 1984
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
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 K841228.
PULSE GENERATOR 678L
K841233 · Siemens Elema AB · Jul 1984
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
K842081 · Cook Pacemaker Corp. · Jul 1984
PULSE GENERATOR 728, 728B & 728L
K841226 · Siemens Elema AB · Jun 1984
PULSE GENERATOR 688B & 688L
K841231 · Siemens Elema AB · Jun 1984
PULSE GENERATOR 698, 698B & 698L
K841229 · Siemens Elema AB · Jun 1984
NEOS M
K841636 · Biotronik Sales, Inc. · Jun 1984