Data / Medical devices / Italy / Gambro Dasco S.P.A., Monitors Division
Gambro Dasco S.P.A., Monitors Division: FDA-registered device maker in MEDOLLA Modena, Italy, 4 510(k) clearances
Gambro Dasco S.P.A., Monitors Division is registered with the FDA (registration 9616240) in MEDOLLA Modena, Italy. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 1, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616240
- FEI number
- 3002807196
- Address
- Via Modenese,66, MEDOLLA Modena, Italy, 41036
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Manufacturer
- First device listed
- September 6, 2019
- Registered through
- 2026
- Brand names listed
- AK 98 Dialysis Machine, CleanCart A, CleanCart C, AK 98 Dialysis Machine, PrisMax System Version 2, PrisMax System Version 3, TherMax
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2025 | K250508 | AK 98 Dialysis Machine (955607) | KDI | Substantially Equivalent | Vantive US Healthcare, LLC | accessdata.fda.gov |
| September 14, 2023 | K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | KDI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| March 13, 2020 | K193482 | PrisMax System Version 3 | KDI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 25, 2019 | K190910 | PrisMax System Version 2 | KDI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
Compare with other makers
Updated August 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.