510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050443Substantially Equivalent

Accu-Lead

Kentec Medical, LLC, Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050443 is the FDA 510(k) clearance record for ACCU-LEAD, a class II device, cleared for Kentec Medical, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 6 510(k) clearances for Kentec Medical, Inc., from to . As of , FDA records show no recalls naming K050443.

Clearance record

Decision date
Received
(192 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Kentec Medical, Inc. 20492 Crescent Bay Dr., Lake Forest CA
510(k) summary
Summary PDF
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