510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053332Substantially Equivalent

Breath Alcohol Test System, Model Al 2500

Sentech Korea Corp., Palisades Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053332 is the FDA 510(k) clearance record for BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500, a class I device, cleared for Sentech Korea Corp. on under FDA product code DJZ (Devices, Breath Trapping, Alcohol). FDA records list 3 510(k) clearances for Sentech Korea Corp., from to . As of , FDA records show no recalls naming K053332.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DJZ Devices, Breath Trapping, Alcohol
Regulation
21 CFR 862.3050
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Sentech Korea Corp. 21 Grand Ave. Suite 103, Palisades Park NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJZ

Trailing 12 months

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

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