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

LFW — Predicate Candidate Screening

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

67 daysmedian FDA review time

136 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K964670	ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN	Roche Diagnostic Systems, Inc.	1997-02-04	75	0
K944371	TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR	Sigma Diagnostics, Inc.	1994-11-10	64	0
K941614	AXSYM TOBRAMYCIN	Abbott Laboratories	1994-08-18	136	0
K912143	CEDIA(R) TOBRAMYCIN ASSAY	Microgenics Corp.	1991-07-26	72	2
K900707	MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR	Innotron of Oregon, Inc.	1990-04-20	67	0
K894531	FPR TOBRAMYCIN KIT	Colony Laboratories, Inc.	1989-09-01	43	0
K872562	INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET	Innotron of Oregon, Inc.	1987-08-17	54	0
K854392	TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU	Windsor Laboratories, Inc.	1985-12-05	35	0
K843828	COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA	Roche Diagnostic Systems, Inc.	1985-02-01	126	0
K841866	INNOFLOUR TOBRAMYCIN	Innotron Diagnostics	1984-05-31	27	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