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

Oxis Intl., Inc. — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

65 daysmedian FDA review time

98 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K972331	INNOFLUOR GENTAMICIN ASSAY SYSTEM	Oxis Intl., Inc.	1997-08-01	39
K972330	INNOFLUOR PHENOBARBITAL ASSAY SYSTEM	Oxis Intl., Inc.	1997-07-14	21
K970509	INNOFLOUR CALIBRATOR REAGENT SET	Oxis Intl., Inc.	1997-05-12	90
K970510	INNOFLOUR TOPIRAMATE REAGENT SET	Oxis Intl., Inc.	1997-05-12	90
K970517	INNOFLUOR TOPIRAMATE CONTROL SET	Oxis Intl., Inc.	1997-05-12	90
K955568	INNOFLUOR QUINIDINE ASSAY SYSTEM	Oxis Intl., Inc.	1996-04-04	120
K955570	INNOFLUOR AMIKACIN ASSAY SYSTEM	Oxis Intl., Inc.	1996-02-09	65
K955569	INNOFLUOR GENTAMICIN ASSAY SYSTEM	Oxis Intl., Inc.	1996-02-09	65
K955562	INNOFLUOR PHENYTOIN ASSAY SYSTEM	Oxis Intl., Inc.	1996-01-24	49
K955567	INNOFLUOR THEOPHYLLINE ASSAY SYSTEM	Oxis Intl., Inc.	1996-01-24	49
K950346	B-L RED(TM) DISCS	Oxis Intl., Inc.	1995-05-05	98

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