Atlas FDA

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

Maine Standards Company, LLC · Predicate Candidate Screening

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

97 daysmedian FDA review time
240 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KMaine Standards Company, LLC2017-06-21900
K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC2017-03-16930
K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KMaine Standards Company, LLC2017-01-05990
K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC2016-06-032400
K142964VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC2015-04-301980
K133550VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KMaine Standards Company, LLC2014-02-05780
K110880VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KMaine Standards Company, LLC2011-07-05970

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