510(k) · Cleared

Cleared

Ethyl Alcohol Assay

K923783510(k) TraditionalCleared Jan 21, 1993177-day reviewClass II21 CFR 862.3040

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

Diagnostic Reagents, Inc. · DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Cleared on Jan 21, 1993 after a 177-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided: Jan 21, 1993
Review: 177 days
Class: Class II
Product code: DMT
Recalls: None
Predicates: 0

3 later devices descend from it, 2 citing it directly.

This deviceK923783 Ethyl Alcohol AssayDiagnostic Reagents, Inc. · 1993
Descendant · cites it directly · 1 of its ownK032461 Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc. · 2003 · Recalled
Descendant · 2 generations on · 0 of its ownK181553 Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation · 2018
Descendant · cites it directly · 0 of its ownK971506 Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol…Beckman Instruments, Inc. · 1997

Most influential descendants

Showing 3 of 3 · See all

K032461Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc. · 2003 · cites it directly1descendant
K181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation · 2018 · 2 generations on0descendants
K971506Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol CalibratorBeckman Instruments, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923783	Ethyl Alcohol Assay	Diagnostic Reagents, Inc.	1993	—
+1	K032461	Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221	Lin-Zhi International, Inc.	2003	3
+2	K181553	Immunalysis Ethyl Alcohol Enzyme Assay	Immunalysis Corporation	2018	—
+1	K971506	Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator	Beckman Instruments, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2003	1	0
2018	1	0

FIG. 1 — Lineage of K923783, 1993–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in DMT? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032461	Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221	Lin-Zhi International, Inc.	2003	1
K971506	Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator	Beckman Instruments, Inc.	1997	0

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?

Of its descendants, K032461 (Lin-Zhi International, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DMT devices

DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DMT

FDA has decided no DMT device since 2007.

Median 510(k) review, days · DMT

Too few DMT 510(k)s in any year since 2007 to give a median.

Recalls per year · DMT

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DMT

2in 2011

2007high 2 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	2
2012	—	0	0
2013	—	1	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K923783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923783: Ethyl Alcohol Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923783

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026