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

DNN · Predicate Candidate Screening

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

41 daysmedian FDA review time

78 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K990516	ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS	Emd Chemicals, Inc.	1999-03-31	41	3
K973054	ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS	Emd Chemicals, Inc.	1997-10-01	47	0
K924733	ETHYL ALCOHOL CALIBRATORS & CONTROL	Diagnostic Reagents, Inc.	1992-12-09	78	0
K882117	ETHYL ALCOHOL STANDARD	Verichem Laboratories, Inc.	1988-08-04	77	3
K853532	ALCOHOL CALIBRATORS	Diagnostic Systems	1985-09-16	24	0
K810466	ETHYL ALCOHOL SERUM CALIBRATOR	Syva Co.	1981-03-06	11	0
K802620	EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR	Syva Co.	1980-10-31	11	0

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