510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904185Substantially Equivalent

Sensatrace

Ludlow Corp., Technical Papers Division, Chicopee MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904185 is the FDA 510(k) clearance record for SENSATRACE, a class II device, cleared for Ludlow Corp., Technical Papers Division on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list one 510(k) clearance for Ludlow Corp., Technical Papers Division. As of , FDA records show no recalls naming K904185.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Ludlow Corp., Technical Papers Division Two Ludlow Park, Chicopee MA
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

FDA records show no clearances under product code DRX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRX, 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