Cleared Traditional

K855139 - FLEXON TEMPORARY CARDIAC CONDUCTIVE MUL...

K855139 is an FDA 510(k) clearance for FLEXON TEMPORARY CARDIAC CONDUCTIVE MUL..., manufactured by Davis & Geck, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K855139 · Davis & Geck, Inc. · Cardiovascular device
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Feb 1986
Decision
65d
Days
Class 2
Risk

K855139 is an FDA 510(k) clearance for the FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT. 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 February 26, 1986 after a review of 65 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

FDA 510(k) Submission Details - K855139

510(k) Number K855139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date February 26, 1986
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
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 81
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K855139.
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · Deknatel, Inc. · Nov 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · Medtronic Vascular · Sep 1987
TB SERIES BIPOLAR PACING LEADS
K861403 · Oscor Medical Corp. · Jun 1986
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · C.R. Bard, Inc. · Sep 1985