Cleared Traditional

K891231 - OPTIMA MPT AND SPT PACEMAKERS

K891231 is an FDA 510(k) clearance for OPTIMA MPT AND SPT PACEMAKERS, 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 189-day FDA review.

K891231 · Telectronics, Inc. · Cardiovascular device
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Sep 1989
Decision
189d
Days
Class 3
Risk

K891231 is an FDA 510(k) clearance for the OPTIMA MPT AND SPT PACEMAKERS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on September 12, 1989 after a review of 189 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, Inc. devices

FDA 510(k) Submission Details - K891231

510(k) Number K891231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date September 12, 1989
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
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 K891231.
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
K895495 · Medtronic Vascular · Sep 1989
OPUS MODELS 4033 AND 4034
K894267 · Ela Medical, 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