Data / Medical devices / United States / Gambro UF Solutions LLC
Gambro UF Solutions LLC: FDA-registered device maker in Plymouth, MN, United States, 10 510(k) clearances
Gambro UF Solutions LLC is registered with the FDA (registration 3003504604) in Plymouth, MN, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003504604
- Address
- 1405 Xenium Ln N, Suite 150, Plymouth, MN, United States, 55441
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Specification developer
- First device listed
- September 27, 1983
- Registered through
- 2026
- Brand names listed
- 15L Cycler Drainage Bag, Amia Automated PD System with Sharesource, Automated Dialysis Cycler System, Automated PD Set with Cassette 4-Prong, Cycler Set, Cycler Sets for Peritoneal Dialysis, Effluent Sample Bag, HomeChoice Low Recirculation Volume APD Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Line | FKK | 1 | Specification developer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Specification developer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 12, 2024 | K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | KDJ | Substantially Equivalent | Baxter Healthcare | accessdata.fda.gov |
| March 18, 2022 | K214016 | 15L Cycler Drainage Bag | KDJ | 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 |
| October 29, 2015 | K152129 | FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution | KDJ | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| October 9, 2015 | K151525 | Amia Automated PD System with Sharesource | FKX | Substantially Equivalent | Deka Research and Development | accessdata.fda.gov |
| March 30, 2011 | K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R | FKX | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 5, 2001 | K012988 | HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 | FKX | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| March 4, 1994 | K923065 | BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL | FKX | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 13, 1979 | K791899 | CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 | KDJ | Substantially Equivalent | Travenol Laboratories, S.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, For Peritoneal Dialysis, Disposable
- All makers of System, Peritoneal, Automatic Delivery
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Clamp, Line
Updated March 12, 2024. 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.