Kuros Biosciences B.V: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Kuros Biosciences B.V” (first 2017, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 120 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 86 |
| 2018 | 1 | 136 |
| 2019 | 1 | 121 |
| 2020 | 0 | — |
| 2021 | 1 | 133 |
| 2022 | 2 | 113 |
| 2023 | 3 | 54 |
| 2024 | 2 | 108 |
| 2025 | 1 | 196 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kuros Biosciences B.V took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 11 | 11 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Kuros Biosciences B.V 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243474 | MagnetOs MIS | MQV | 2025-05-23 | 196 |
| K240442 | MagnetOs Putty | MQV | 2024-04-01 | 47 |
| K232347 | MagnetOs Granules | MQV | 2024-01-19 | 168 |
| K230736 | MagnetOs Putty | MQV | 2023-12-20 | 278 |
| K233607 | MagnetOs Easypack Putty | MQV | 2023-12-15 | 36 |
| K233245 | MagnetOs Flex Matrix | MQV | 2023-11-21 | 54 |
| K213959 | MagnetOs Flex Matrix | MQV | 2022-04-14 | 118 |
| K213111 | MagnetOs granules | MQV | 2022-01-10 | 108 |
| K211201 | MagnetOs Easypack Putty | MQV | 2021-09-02 | 133 |
| K183092 | Kuros TLIF Cage | MAX | 2019-03-08 | 121 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kuros Biosciences B.V.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kuros Biosciences (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kuros Biosciences B.V?
FDA lists 12 510(k) clearances under the applicant name “Kuros Biosciences B.V” (first 2017, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kuros Biosciences B.V?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kuros Biosciences B.V is 120 days. Since 2017: 120 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kuros Biosciences B.V?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 11); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 12 Kuros Biosciences B.V clearances with predicates and recalls
- Run predicate analysis for product code MQV, Kuros Biosciences B.V's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.