Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DML — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

62 daysmedian FDA review time

77 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K013538	ETHANOL	Abbott Laboratories	2001-12-14	51
K993980	SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409U	Syva Co.	2000-02-01	69
K963197	ON.SITE ALCOHOL	Ansys, Inc.	1996-09-19	35
K953765	AXSYM REA ETHANOL	Abbott Laboratories	1995-09-27	47
K952839	BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY	Boehringer Mannheim Corp.	1995-08-24	64
K923337	ON*SITE ALCOHOL	Toxi-Lab, Inc.	1993-01-12	208
K914777	SIGMA PROCEDURE NO. 333-UV	Sigma Diagnostics, Inc.	1991-12-27	65
K874382	RAICHEM(TM) ALCOHOL REAGENT	Reagents Applications, Inc.	1988-01-11	77
K872180	KINETIC 610 ETHANOL	American Monitor Corp.	1987-07-07	29
K863419	EMDS(TM) ALCOHOL TESTPACKS, #67691/95	Em Diagnostic Systems, Inc.	1986-09-29	26
K840769	PARAMAX ALCOHOL REAGENT	American Dade	1984-04-13	65
K840400	EMIT ST SERUM ETHYL ALCOHOL ASSAY	Syva Co.	1984-03-23	53
K840171	EMIT ST URINE ETHYL ALCOHOL ASSAY	Syva Co.	1984-03-19	62

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda