Cleared Traditional

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (K903186) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K903186 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Jan 1991
Decision
183d
Days
Class 3
Risk

K903186 is an FDA 510(k) clearance for the OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 183 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 Telectronics Pacing Systems, Inc. devices

Submission Details

510(k) Number K903186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1990
Decision Date January 18, 1991
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K903186.
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · Medtronic Vascular · May 1993
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
K920530 · Intermedics, Inc. · Mar 1992
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · Intermedics, Inc. · May 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · Medtronic Vascular · Jan 1991
VACUUM BAKE CYCLE
K904892 · Medtronic Vascular · Dec 1990
IMPLANTABLE PULSE DEVICES
K903919 · Medtronic Vascular · Oct 1990