Cleared Traditional

K012218 - LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES

K012218 is an FDA 510(k) clearance for LUDLOW GRADIENT EDGE ADULT & PEDIATRIC ..., manufactured by The Ludlow Company LP. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K012218 · The Ludlow Company LP · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
88d
Days
Class 2
Risk

K012218 is an FDA 510(k) clearance for the LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by The Ludlow Company LP (Chicopee, US). The FDA issued a Cleared decision on October 12, 2001 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 The Ludlow Company LP devices

FDA 510(k) Submission Details - K012218

510(k) Number K012218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date October 12, 2001
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.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 57
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K012218.
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404 · Katecho, Inc. · Oct 2001
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
K000660 · Medical Data Electronics · Mar 2000
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196 · Tz Medical, Inc. · Sep 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
K983232 · Tz Medical, Inc. · Sep 1999
PORTABLE INTENSIVE CARE UNIT
K974034 · Medical Research Laboratories, Inc. · Mar 1998
CARDIOSERV P
K962547 · Marquette Electronics, Inc. · Mar 1997