Cleared Traditional

K922268 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491

K922268 is an FDA 510(k) clearance for UNIPOLAR PEDIATRIC TEMPORARY PACING LEA..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with 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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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

FDA 510(k) Submission Details - K922268

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.

LDF Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K922268.
SILICORE SEMI-FLOATER
K934787 · Electro-Catheter Corp. · Feb 1995
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069 · J-Lloyd Medical, Inc. · Jan 1994
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