Cleared Traditional

K903186 - OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE

K903186 is an FDA 510(k) clearance for OPTIMA SERIES II MODEL 147B SINGLE CHAM..., manufactured by Telectronics Pacing Systems, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 183-day FDA review.

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

FDA 510(k) Submission Details - K903186

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K903186.
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · Cardiac Control Systems, Inc. · May 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · Intermedics, Inc. · May 1991
TRIOS 02
K905087 · Biotronik, GmbH & Co. · May 1991
MEDTRONIC MODEL 5301B TEST CABLE
K904602 · Medtronic Vascular · Jan 1991
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
K904941 · Cardiac Control Systems, Inc. · Jan 1991
VACUUM BAKE CYCLE
K904892 · Medtronic Vascular · Dec 1990