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

Maine Standards Co. — Predicate Candidate Screening

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

50 daysmedian FDA review time

85 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K123127	VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MO	Maine Standards Co.	2013-06-14	253
K113524	VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT	Maine Standards Co.	2012-01-27	59
K103271	MSC LIPID CONTROL	Maine Standards Co.	2011-01-25	81
K091225	VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINE	Maine Standards Co.	2009-06-25	59
K090475	VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET,	Maine Standards Co.	2009-04-16	51
K083891	VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 90	Maine Standards Co.	2009-03-23	84
K082067	MSC LIPID CONTROL	Maine Standards Co.	2008-08-22	31
K072246	VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MO	Maine Standards Co.	2007-09-14	32
K062501	VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST S	Maine Standards Co.	2006-09-29	35
K053247	VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST	Maine Standards Co.	2006-01-13	53
K050504	VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS	Maine Standards Co.	2005-03-25	25
K041975	VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODE	Maine Standards Co.	2004-10-15	85
K033879	VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126	Maine Standards Co.	2004-02-27	74
K023410	VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 11	Maine Standards Co.	2003-01-06	88
K023352	VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109	Maine Standards Co.	2002-11-22	46
K020450	VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108	Maine Standards Co.	2002-03-21	38
K013265	VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 100	Maine Standards Co.	2001-11-20	50
K013119	VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10	Maine Standards Co.	2001-11-16	59
K012118	VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 100	Maine Standards Co.	2001-08-20	45
K012119	VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 100	Maine Standards Co.	2001-08-20	45
K012122	VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 100	Maine Standards Co.	2001-08-20	45
K012120	VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 100	Maine Standards Co.	2001-08-20	45
K012117	VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 100	Maine Standards Co.	2001-08-20	45

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