Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ranfac Corporation — 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) |
|---|---|---|---|---|---|
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BM | Ranfac Corporation | 2023-02-21 | 78 | 0 |
| K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corporation | 2020-09-18 | 37 | 0 |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Twee | Ranfac Corporation | 2019-06-12 | 131 | 0 |
| K183146 | Ranfac Cartilage Biopsy Needle | Ranfac Corporation | 2019-04-25 | 163 | 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