Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baumer Ortopedia , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
398 daysmedian FDA review time
425 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930966 | BAUMER PLATES | Baumer Ortopedia , Ltd. | 1994-04-25 | 425 | 0 |
| K930969 | BAUMER PINS | Baumer Ortopedia , Ltd. | 1994-03-29 | 398 | 0 |
| K930972 | INTRAMEDULLARY SYSTEMS | Baumer Ortopedia , Ltd. | 1994-03-29 | 398 | 0 |
| K930967 | BAUMER STAPLES | Baumer Ortopedia , Ltd. | 1994-03-07 | 376 | 0 |
| K930970 | BAUMER SCREWS | Baumer Ortopedia , Ltd. | 1994-01-07 | 317 | 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