Cleared Traditional

K884522 - MODEL 5650 OPTIMATE PERSONAL PROGRAMMER

K884522 is an FDA 510(k) clearance for MODEL 5650 OPTIMATE PERSONAL PROGRAMMER, manufactured by Teletronics, Inc.. The device is a Class 3 Cardiovascular device with product code KRG cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K884522 · Teletronics, Inc. · Cardiovascular device
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Aug 1989
Decision
302d
Days
Class 3
Risk

K884522 is an FDA 510(k) clearance for the MODEL 5650 OPTIMATE PERSONAL PROGRAMMER. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Teletronics, Inc. (Suffield, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3700 - 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 Teletronics, Inc. devices

FDA 510(k) Submission Details - K884522

510(k) Number K884522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1988
Decision Date August 25, 1989
Days to Decision 302 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

KRG Device Classification - Class 3, Premarket Approval

Product Code KRG Programmer, Pacemaker
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3700
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 - KRG Programmer, Pacemaker

All 22
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K884522.
INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04
K933278 · Intermedics, Inc. · Mar 1995
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K880738 · Medtronic Vascular · Nov 1988
MODEL 1740 PERSONAL POCKET PROGRAMMER
K864712 · Telectronics, Inc. · Dec 1987
MODEL 5600B PROGRAMMER, PACEMAKER
K871986 · Telectronics, Inc. · Jun 1987
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · Cardiac Pacemakers, Inc. · Dec 1986
PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580
K863045 · Cardiac Pacemakers, Inc. · Sep 1986