Cleared Traditional

K871986 - MODEL 5600B PROGRAMMER, PACEMAKER (FDA 510(k) Clearance)

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

K871986 · Telectronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
33d
Days
Class 3
Risk

K871986 is an FDA 510(k) clearance for the MODEL 5600B PROGRAMMER, PACEMAKER. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on June 24, 1987 after a review of 33 days - a notably fast clearance cycle.

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 K871986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1987
Decision Date June 24, 1987
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
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.