Cleared Traditional

K841230 - PULSE GENERATOR 686

K841230 is an FDA 510(k) clearance for PULSE GENERATOR 686, 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 256-day FDA review.

K841230 · Siemens Elema AB · Cardiovascular device
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Dec 1984
Decision
256d
Days
Class 3
Risk

K841230 is an FDA 510(k) clearance for the PULSE GENERATOR 686, 686B 686L. 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 December 3, 1984 after a review of 256 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 - K841230

510(k) Number K841230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1984
Decision Date December 03, 1984
Days to Decision 256 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
131d slower than avg
Panel avg: 125d · This submission: 256d
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 K841230.
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · Ela Medical, Inc. · Jan 1985
VIVALITH II 301 PULSE GENERATOR
K844334 · Pacesetter Systems · Jan 1985
PULSE GENERATOR 689, 689B & 689L
K841225 · Siemens Elema AB · Dec 1984
PULSE GENERATOR 696, 696B & 696L
K841232 · Siemens Elema AB · Dec 1984
MULTILITH 2 PULSE GENERATOR 1141 & 2141
K842220 · Ela Medical, Inc. · Nov 1984
IMPLANTABLE PROGRAMMABLE PULSE GENERAT
K842473 · Telectronics, Inc. · Oct 1984