Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Promedical , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
75 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954596 | PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM | Promedical , Ltd. | 1995-10-07 | 4 | 0 |
| K952350 | JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE | Promedical , Ltd. | 1995-07-17 | 59 | 0 |
| K951598 | PRO-B BIOPSY NEEDLE | Promedical , Ltd. | 1995-04-21 | 14 | 0 |
| K944944 | CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NE | Promedical , Ltd. | 1994-12-21 | 75 | 0 |
| K944942 | BREAST LESION LOCALIZATION NEEDLE | Promedical , Ltd. | 1994-11-04 | 28 | 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