Cleared Traditional

K922268 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEA...

K922268 is the FDA 510(k) clearance for UNIPOLAR PEDIATRIC TEMPORARY PACING LEA... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K922268 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 1992
Decision
193d
Days
Class 2
Risk

K922268 is an FDA 510(k) clearance for the UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 193 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 Medtronic Vascular devices

Submission Details

510(k) Number K922268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date November 23, 1992
Days to Decision 193 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 125d · This submission: 193d
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 77
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K922268.
MULTIPACE
K934785 · Electro-Catheter Corp. · Jul 1995
SILICORE SEMI-FLOATER
K934787 · Electro-Catheter Corp. · Feb 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · Medtronic Vascular · Nov 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · Medtronic Vascular · Oct 1992
PACEL(TM) FLOW DIRECTED PACING CATHETER
K914185 · Daig Corp. · Jan 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · Medtronic Vascular · Oct 1990