510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012218Substantially Equivalent

Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes

The Ludlow Company LP, Chicopee MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012218 is the FDA 510(k) clearance record for LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES, a class II device, cleared for The Ludlow Company LP on under FDA product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)). FDA records list 3 510(k) clearances for The Ludlow Company LP, from to . As of , FDA records show 8 recalls naming K012218.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation
21 CFR 870.5550
Device class
Class II
Review panel
Cardiovascular
Applicant
The Ludlow Company LP Two Ludlow Park Dr., Chicopee MA
510(k) summary
Statement
Third party review
No

Clearances, product code DRO

Trailing 12 months

FDA records hold no clearances under product code DRO in the trailing twelve months.

FDA records show no clearances under product code DRO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260