Cleared Traditional

K813079 - BIPOLAR OPTIMA MP #255

K813079 is an FDA 510(k) clearance for BIPOLAR OPTIMA MP #255, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K813079 · Telectronics, Inc. · Cardiovascular device
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Dec 1981
Decision
38d
Days
Class 3
Risk

K813079 is an FDA 510(k) clearance for the BIPOLAR OPTIMA MP #255. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1981 after a review of 38 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K813079

510(k) Number K813079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date December 10, 1981
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K813079.
COMMAND P5
K813534 · Cardiac Pacemakers, Inc. · Jan 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576 · Siemens Elema AB · Jan 1982
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610 · Siemens Corp. · Dec 1981
DIRECTIONAL BOOT
K813150 · Pacesetter Systems · Dec 1981
MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
K812832 · Cook Pacemaker Corp. · Nov 1981
MODEL 325T PROGRAMMABLE PULSE GENERATOR
K812358 · Cook Pacemaker Corp. · Oct 1981