BAAT Medical Products B.V.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “BAAT Medical Products B.V.” (first 2020, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 125 days. Since 2017 the median was 125 days, against 98 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 |
|---|---|---|
| 2020 | 1 | 56 |
| 2021 | 1 | 125 |
| 2022 | 0 | — |
| 2023 | 1 | 341 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 143 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name BAAT Medical Products B.V. took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| PGM | Growing Rod System | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent BAAT Medical Products B.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254176 | SINEFIX | MBI | 2026-03-16 | 83 |
| K251961 | SDS Growing Rod | PGM | 2026-01-15 | 203 |
| K220966 | SINEFIX | MBI | 2023-03-08 | 341 |
| K211474 | Kleiner KG2 System | MAX | 2021-09-14 | 125 |
| K201830 | ANSER Clavicle Pin | HSB | 2020-08-27 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named BAAT Medical Products 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.
Device clinical trials
An industry sponsor named BAAT Medical Products B.V. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05721560: SINEFIX-2022 Pilot Phase (Active not recruiting, started 2023-09-12)
Frequently asked questions
How many FDA 510(k) clearances are listed under BAAT Medical Products B.V.?
FDA lists 5 510(k) clearances under the applicant name “BAAT Medical Products B.V.” (first 2020, latest 2026), across 4 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 BAAT Medical Products B.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name BAAT Medical Products B.V. is 125 days. Since 2017: 125 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under BAAT Medical Products B.V.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 5 BAAT Medical Products B.V. clearances with predicates and recalls
- Run predicate analysis for product code MBI, BAAT Medical Products 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.