Cleared Traditional

K884411 - OPTIMA MPT AND SPT PACEMAKERS

K884411 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 98-day FDA review.

K884411 · Telectronics, Inc. · Cardiovascular device
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Jan 1989
Decision
98d
Days
Class 3
Risk

K884411 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 January 26, 1989 after a review of 98 days - within the typical 510(k) review window.

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 - K884411

510(k) Number K884411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date January 26, 1989
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K884411.
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
UNILITH 3 MODELS 7580/7583/7680/7683
K883037 · Ela Medical, Inc. · Jan 1989
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
K883755 · Medtronic Vascular · Nov 1988
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
K884215 · Medtronic Vascular · Nov 1988