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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Thermofisher Scientific OY · Predicate Candidate Screening

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

154 daysmedian FDA review time
252 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110035INDIKOThermofisher Scientific OY2011-06-281740
K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OY2008-05-291880
K073612URIC ACID (AOX), SCAL, NORTROL, ABTROLThermofisher Scientific OY2008-05-231540
K073191ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROLThermofisher Scientific OY2008-02-281070
K073355CALCIUM, SCAL, NORTROL, ABTROLThermofisher Scientific OY2008-02-28910
K070824CREATININE (ENZYMATIC)Thermofisher Scientific OY2007-12-032520
K071340CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROLThermofisher Scientific OY2007-10-051440
K071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROThermofisher Scientific OY2007-10-031170

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