510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K003804Substantially Equivalent

Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

Niko Medical Products, Fort Worth TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K003804 is the FDA 510(k) clearance record for SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801, a class II device, cleared for Niko Medical Products on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list one 510(k) clearance for Niko Medical Products. As of , FDA records show no recalls naming K003804.

Clearance record

Decision date
Received
(265 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Niko Medical Products 6401 Meadows W., Fort Worth TX
510(k) summary
Summary
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