Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermo Orion — 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) |
|---|---|---|---|---|---|
| K023792 | CALIBRATION PACK, MODELS A9100-101S AND A9100-103S | Thermo Orion | 2003-01-31 | 79 | 0 |
| K844559 | MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTI | Thermo Orion | 1985-01-18 | 58 | 0 |
| K821822 | MODEL 1020 NA/K ANALYZER | Thermo Orion | 1982-07-02 | 10 | 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