Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JRI · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873656 | MEDATRON CUVETTE DISC | Medatron, Inc. | 1987-12-14 | 95 | 0 |
| K780888 | THERMO SET ELECTRONIC TEM. CONTROLLER | Gilford Instrument Laboratories, Inc. | 1978-06-28 | 33 | 0 |
| K760769 | TEMPERATURE REGULATED FIVE CELL HOLDERS | The Perkin-Elmer Corp. | 1976-11-30 | 57 | 0 |
| K760197 | ACCUVETTE II | Coulter Electronics, Inc. | 1976-07-19 | 13 | 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