Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kuros Biosciences B.V — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
121 daysmedian FDA review time
196 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025-05-23 | 196 | 0 |
| K240442 | MagnetOs Putty | Kuros Biosciences B.V | 2024-04-01 | 47 | 0 |
| K232347 | MagnetOs Granules | Kuros Biosciences B.V | 2024-01-19 | 168 | 0 |
| K230736 | MagnetOs Putty | Kuros Biosciences B.V | 2023-12-20 | 278 | 0 |
| K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023-12-15 | 36 | 0 |
| K233245 | MagnetOs Flex Matrix | Kuros Biosciences B.V | 2023-11-21 | 54 | 0 |
| K213959 | MagnetOs Flex Matrix | Kuros Biosciences B.V | 2022-04-14 | 118 | 0 |
| K213111 | MagnetOs granules | Kuros Biosciences B.V | 2022-01-10 | 108 | 0 |
| K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021-09-02 | 133 | 0 |
| K183092 | Kuros TLIF Cage | Kuros Biosciences B.V | 2019-03-08 | 121 | 0 |
| K181958 | MagnetOs Putty | Kuros Biosciences B.V | 2018-12-06 | 136 | 0 |
| K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017-08-24 | 86 | 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