510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854757Substantially Equivalent

5000 Series ECG Electrodes

Alternative Design Systems, Inc., Carlstadt NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854757 is the FDA 510(k) clearance record for 5000 SERIES ECG ELECTRODES, a class II device, cleared for Alternative Design Systems, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 6 510(k) clearances for Alternative Design Systems, Inc., from to . As of , FDA records show no recalls naming K854757.

Clearance record

Decision date
Received
(147 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Alternative Design Systems, Inc. 419 Hackensack Ave., Carlstadt NJ
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