Atlas FDA

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

Thermo Electron OY — Predicate Candidate Screening

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

275 daysmedian FDA review time
366 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NThermo Electron OY2007-10-173660
K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORThermo Electron OY2007-10-093000
K063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTRThermo Electron OY2007-10-053570
K063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CThermo Electron OY2007-09-272750
K063086TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIThermo Electron OY2007-08-083020
K063209HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMALThermo Electron OY2007-03-211490
K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTThermo Electron OY2007-03-191540
K063647CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGHThermo Electron OY2007-03-12950
K061107DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247Thermo Electron OY2006-08-081100

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