Cleared Traditional

UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER (K896438) - FDA 510(k) Clearance

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

K896438 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Apr 1990
Decision
152d
Days
Class 2
Risk

K896438 is an FDA 510(k) clearance for the UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Pacing Systems, Inc. devices

Submission Details

510(k) Number K896438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1989
Decision Date April 10, 1990
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 37
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K896438.
MODEL 5857-3M LEAD END CAP KIT
K911048 · Medtronic Vascular · Apr 1991
MODEL 5866-37M LEAD ADAPTOR KIT
K904575 · Medtronic Vascular · Feb 1991
MODEL 5866-34 LEAD ADAPTOR KIT
K900627 · Medtronic Vascular · Apr 1990
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.
K894976 · Medtronic Vascular · Oct 1989
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · Intermedics, Inc. · Sep 1989
PACEMAKER LEAD ADAPTER
K862656 · Cordis Corp. · Jul 1986