Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Preco, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853144 | CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 | Preco, Inc. | 1985-10-16 | 79 | 0 |
| K852751 | TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST | Preco, Inc. | 1985-08-20 | 53 | 0 |
| K853054 | RF CARD TEST | Preco, Inc. | 1985-08-01 | 13 | 0 |
| K850604 | PRECO PREGNANCY RAPID CARD TEST, HEM #2028 | Preco, Inc. | 1985-04-08 | 52 | 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