Cleared Traditional

TELECTRONICS MODEL 2401 (K831697) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831697 · Seamed Corp. · Cardiovascular device
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Sep 1984
Decision
468d
Days
Class 2
Risk

K831697 is an FDA 510(k) clearance for the TELECTRONICS MODEL 2401. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Seamed Corp. (Walker, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Seamed Corp. devices

Submission Details

510(k) Number K831697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1983
Decision Date September 04, 1984
Days to Decision 468 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 125d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTC Analyzer, Pacemaker Generator Function

All 8
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K831697.
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · Medtronic Vascular · Jan 1989
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · Medtronic Vascular · Jul 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · Cordis Corp. · May 1985
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · Medtronic Vascular · Jun 1982
PACER SYSTEMS ANALYZER (CORDIS)
K760013 · Cordis Corp. · Jul 1976