Cleared Traditional

DISPOSABLE TEMPORARY PACING WIRE (K023174) - FDA 510(k) Clearance

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

K023174 · River Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
261d
Days
Class 2
Risk

K023174 is an FDA 510(k) clearance for the DISPOSABLE TEMPORARY PACING WIRE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by River Medical, Inc. (Portland, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 261 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 River Medical, Inc. devices

Submission Details

510(k) Number K023174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date June 11, 2003
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
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 K023174.
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
K140972 · Medtronic, Inc. · Jun 2014
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · Medtronic Vascular · Sep 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · Medtronic Vascular · Sep 2004
STEELEX ELECTRODE SET
K030556 · Aesculap, Inc. · Apr 2003
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · Medtronic Vascular · Aug 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
K012454 · Medtronic Vascular · Aug 2001