Cleared Traditional

K894185 - OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR

K894185 is an FDA 510(k) clearance for OPTIMA MPT SERIES III PACEMAKER, 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 62-day FDA review.

K894185 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Aug 1989
Decision
62d
Days
Class 3
Risk

K894185 is an FDA 510(k) clearance for the OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR. 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 August 17, 1989 after a review of 62 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 Pacing Systems, Inc. devices

FDA 510(k) Submission Details - K894185

510(k) Number K894185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date August 17, 1989
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K894185.
OPUS MODELS 4033 AND 4034
K894267 · Ela Medical, Inc. · Sep 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231 · Telectronics, Inc. · Sep 1989
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
K894055 · Medtronic Vascular · Aug 1989
VS-1 MODEL NUMBER 251K PULSE GENERATOR
K885267 · Pacesetter Systems · Mar 1989
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
K890785 · Cardiac Pacemakers, Inc. · Mar 1989
AFP MODEL 262T PULSE GENERATOR
K884733 · Pacesetter Systems · Feb 1989