Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermo Electron Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 | Thermo Electron Corp. | 2007-03-23 | 305 | 0 |
| K062521 | OXALATE URINE CONTROLS (NORMAL AND ELEVATED) | Thermo-Electron Corp. | 2007-03-16 | 200 | 0 |
| K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTR | Thermo-Electron Corp. | 2005-09-23 | 56 | 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