Cleared Traditional

XEMEX TEMPORARY PACING CATHETER A (K904868) - FDA 510(k) Clearance

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

K904868 · Zeon Medical Corp. · Cardiovascular device
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May 1991
Decision
199d
Days
Class 2
Risk

K904868 is an FDA 510(k) clearance for the XEMEX TEMPORARY PACING CATHETER A. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Zeon Medical Corp. (White Plains, US). The FDA issued a Cleared decision on May 16, 1991 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Zeon Medical Corp. devices

Submission Details

510(k) Number K904868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1990
Decision Date May 16, 1991
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 47
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K904868.
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · Medtronic Vascular · Nov 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · Medtronic Vascular · Nov 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · Medtronic Vascular · Oct 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · Medtronic Vascular · Oct 1990
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · Medtronic Vascular · Dec 1989
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988