510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853038Substantially Equivalent

De12 Rapid Trace at-Rest Diagnostic ECG Electrodes

ZOLL Medical Corporation, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853038 is the FDA 510(k) clearance record for DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES, a class II device, cleared for Bio-Detek, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K853038.

Clearance record

Decision date
Received
(172 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Bio-Detek, Inc. 171 Forbes Blvd., Mansfield 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