Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NRN · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140907 | LEECH, MEDICINAL | Carolina Biological Supply Co. | 2015-08-07 | 486 | 0 |
| K132958 | MEDICINAL LEECHES | Biopharm (Uk) , Ltd. | 2014-02-19 | 152 | 0 |
| K040187 | MEDICINAL LEECHES | Ricarimpex Sas | 2004-06-21 | 145 | 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