510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110614Substantially Equivalent

Pad (Personal Alcohol Detector) Breath Alcohol Test System

Seju Engineering Co., Ltd., Yuseong-Gu, Daejeon, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110614 is the FDA 510(k) clearance record for PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM, a class I device, cleared for Seju Engineering Co., Ltd. on under FDA product code DJZ (Devices, Breath Trapping, Alcohol). FDA records list one 510(k) clearance for Seju Engineering Co., Ltd. As of , FDA records show no recalls naming K110614.

Clearance record

Decision date
Received
(263 days to decision)
Product code
DJZ Devices, Breath Trapping, Alcohol
Regulation
21 CFR 862.3050
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Seju Engineering Co., Ltd. Certification Division, Yuseong-Gu, Daejeon, KR
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