Cleared Traditional

K864712 - MODEL 1740 PERSONAL POCKET PROGRAMMER (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K864712 · Telectronics, Inc. · Cardiovascular device
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Dec 1987
Decision
379d
Days
Class 3
Risk

K864712 is an FDA 510(k) clearance for the MODEL 1740 PERSONAL POCKET PROGRAMMER. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on December 17, 1987 after a review of 379 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 Telectronics, Inc. devices

Submission Details

510(k) Number K864712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1986
Decision Date December 17, 1987
Days to Decision 379 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 125d · This submission: 379d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.