Cleared Traditional

K841229 - PULSE GENERATOR 698

K841229 is an FDA 510(k) clearance for PULSE GENERATOR 698, 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 95-day FDA review.

K841229 · Siemens Elema AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
95d
Days
Class 3
Risk

K841229 is an FDA 510(k) clearance for the PULSE GENERATOR 698, 698B & 698L. 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 25, 1984 after a review of 95 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 - K841229

510(k) Number K841229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1984
Decision Date June 25, 1984
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
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 K841229.
PULSE GENERATOR 728, 728B & 728L
K841226 · Siemens Elema AB · Jun 1984
PULSE GENERATOR 718B & 718L
K841228 · Siemens Elema AB · Jun 1984
PULSE GENERATOR 688B & 688L
K841231 · Siemens Elema AB · Jun 1984
NEOS M
K841636 · Biotronik Sales, Inc. · Jun 1984
PULSE GENERATOR KALOS-04
K841950 · Biotronik Sales, Inc. · Jun 1984
PRIMA 236-02 NONPROGRAMMABLE CARDIAC
K841404 · Intermedics, Inc. · May 1984