Data / Medical devices / France / Gambro Industries
Gambro Industries: FDA-registered device maker in MEYZIEU CEDEX Rhone, France, 5 510(k) clearances and 1 PMA approval
Gambro Industries is registered with the FDA (registration 8010182) in MEYZIEU CEDEX Rhone, France. It lists 3 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated April 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010182
- FEI number
- 3002807204
- Address
- 7, Av. Lionel Terray, B.P. 126, MEYZIEU CEDEX Rhone, France, 69883
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 6, 2006
- Registered through
- 2026
- Brand names listed
- DIACLEAR, PRISMAFLEX HF 1000 SET, PRISMAFLEX HF 1400 SET, PRISMAFLEX M100 SET, PRISMAFLEX M150 SET, PRISMAFLEX M60 SET, PRISMAFLEX MONITOR, PRISMAFLEX TPE 2000 SET and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | MDP | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 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 |
|---|---|---|---|---|---|---|
| April 1, 2022 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | KDI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| June 13, 2008 | K080519 | PRISMAFLEX M150 SET | KDI | Substantially Equivalent | Gambro Renal Products, Inc. | accessdata.fda.gov |
| January 6, 2005 | K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS | KDI | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| October 7, 2004 | K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS | KDI | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| November 1, 2001 | K003957 | DIACLEAR ULTRAFILTER | FIP | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 27, 1986 | P830063 | GAMBRO FIBER PLASMAFILTER | MDP | 30 | July 15, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Subsystem, Water Purification
- All makers of Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
Updated July 15, 2026. 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.