510(k) Report

510(k) · Cleared

Cleared

Pad (Personal Alcohol Detector) Breath Alcohol Test System

K110614510(k) TraditionalCleared Nov 21, 2011263-day reviewClass I21 CFR 862.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Seju Engineering Co., Ltd. · DJZ Devices, Breath Trapping, Alcohol

Cleared on Nov 21, 2011 as substantially equivalent to K053332 (Sentech Korea Corp., 2006) after a 263-day review. Its family tree reaches back 1 generation to 2006.

Decided
Nov 21, 2011
Review
263 days
Class
Class I
Product code
DJZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K053332 (2006). No later device cites it as a predicate yet.

K053332 · Breath Alcohol Test System, Model AL 2500 · Sentech Korea Corp. · 20062006200820102012
K053332 · Breath Alcohol Test System, Model AL 2500 · Sentech Korea Corp. · 20060
  1. Root · 1 generation backK053332 Breath Alcohol Test System, Model AL 2500Sentech Korea Corp. · 2006
  2. This deviceK110614 Pad (Personal Alcohol Detector) Breath Alcohol Test SystemSeju Engineering Co., Ltd. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K053332Breath Alcohol Test System, Model AL 2500Sentech Korea Corp.2006—
0 (this device)K110614Pad (Personal Alcohol Detector) Breath Alcohol Test SystemSeju Engineering Co., Ltd.2011—
FIG. 1 — Lineage of K110614, 2006–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DJZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K053332Breath Alcohol Test System, Model AL 2500
Summary page 1
…section 862.3050, Device, breath trapping, alcohol Common/Usual Name: Breath-alcohol test system 2. Equivale nt legally marketed devices Model:AL2500 K Number: K053332 3. Indication for use (Intended use): The PAD Breath Alcohol Tester is a screening device for the rapid detection of alcohol…
Sentech Korea Corp.2006—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All DJZ devices

DJZ Devices, Breath Trapping, Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DJZ

1in 2016

2007: 22008: 52009: 52010: 22011: 32013: 12016: 1
2007high 5 (2008) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DJZ

240in 2011

2008: 149 days median2009: 122 days median2011: 240 days median
2007high 240 (2011) · low 122 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DJZ

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DJZ

3in 2025

2007: 22011: 12019: 12022: 12023: 12025: 3
2007high 3 (2025) · low 0 (2008)2025

MAUDE reports naming product code DJZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—12
2008514900
2009512200
20102—00
2011324001
20120—00
20131—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—01
20230—01
20240—00
20250—03
20260—0—

What is it indicated for?

The PAD Breath Alcohol Test System is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.

Indications for use as stated in the FDA summary.

Recent decisions in DJZ

The DJZ category page

  • K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLC · 2016
  • K123470Pas Alcovisor Mars, Pas Alcovisor SatellitePas Systems International, Inc. · 2013
  • K102225Alco-Breath Tube, Checkpoint Breath Alcohol TestAlcopro, Inc. · 2011
  • K102338Breathscn ProAkers Biosciences, Inc. · 2011
  • K100879ContralcoContralco · 2010

https://510kreport.com/device/K110614 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110614: Pad (Personal Alcohol Detector) Breath Alcohol Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110614

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026