Cleared Traditional

FLEXON TEMPORARY CARDIAC PACER LEAD (K955722) - FDA 510(k) Clearance

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

K955722 · Davis & Geck, Inc. · Cardiovascular device
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Mar 1996
Decision
88d
Days
Class 2
Risk

K955722 is an FDA 510(k) clearance for the FLEXON TEMPORARY CARDIAC PACER LEAD. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on March 15, 1996 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Davis & Geck, Inc. devices

Submission Details

510(k) Number K955722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date March 15, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 50
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K955722.
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · Medtronic Vascular · Nov 1996
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
K955712 · C.R. Bard, Inc. · Oct 1996
RV PACING LEAD
K962467 · Abbott Laboratories · Sep 1996
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809 · Medtronic Vascular · Dec 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · Medtronic Vascular · Nov 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · Medtronic Vascular · Nov 1992