Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MLM — Predicate Candidate Screening

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

147 daysmedian FDA review time

758 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K203833	Tacrolimus Assay Kit	Shanghai Genext Medical Technology Co., Ltd.	2023-01-27	758	0
K173857	Elecsys Tacrolimus	Roche Diagnostics	2018-11-06	321	0
K150168	Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimensio	Siemens Healthcare Diagnostics	2015-11-04	282	2
K123343	THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS	Microgenics Corp.	2013-07-11	253	1
K070820	ARCHITECT TACROLIMUS: MODEL 1L77	Fujirebio Diagnostics,Inc.	2007-08-01	128	1
K063868	MASSTRAK IMMUNOSUPPRESSANTS KIT	Waters Corporation	2007-05-25	147	0
K060502	DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107	Dade Behring, Inc.	2006-05-18	83	3
K060385	EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT	Dade Behring, Inc.	2006-04-06	51	0
K050206	CEDIA TACROLIMUS ASSAY	Microgenics Corp.	2005-03-15	46	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