Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
BAAT Medical Products B.V. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
341 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 | 83 | 0 |
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. | 2026-01-15 | 203 | 0 |
| K220966 | SINEFIX | BAAT Medical Products B.V. | 2023-03-08 | 341 | 0 |
| K211474 | Kleiner KG2 System | BAAT Medical Products B.V. | 2021-09-14 | 125 | 0 |
| K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020-08-27 | 56 | 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