Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Aap Biomaterials GmbH & Co. KG · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123225 | BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONO | Aap Biomaterials GmbH & Co. KG | 2013-03-15 | 151 | 0 |
| K123081 | BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 0 | Aap Biomaterials GmbH & Co. KG | 2013-03-07 | 157 | 1 |
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