Data / Medical devices / United States / Vantive US Healthcare LLC
Vantive US Healthcare LLC: FDA-registered device maker in Mountain Home, AR, United States, 11 510(k) clearances
Vantive US Healthcare LLC is registered with the FDA (registration 2314912) in Mountain Home, AR, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 12, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2314912
- Address
- 1900 North Highway 201, Mountain Home, AR, United States, 72653
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Manufacturer
- First device listed
- September 27, 1983
- Registered through
- 2026
- Brand names listed
- 12 ft Extension Set, 15L Cycler Drainage Bag, 3L Ultra Set CAPD Disposable Y-Set, Amia Automated PD System with Sharesource, Automated Dialysis Cycler System, Automated PD Set with Cassette 4-Prong, Baxter 12' Extension Line, Cycler Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Line | FKK | 1 | Manufacturer | accessdata.fda.gov |
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 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 |
|---|---|---|---|---|---|---|
| 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 |
| October 29, 2015 | K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER | KDJ | Substantially Equivalent | Baxter Healthcare | 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 |
| August 6, 1996 | K961825 | ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 | KDJ | 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 |
| February 22, 1994 | K925403 | BAXTER APD 12' EXTENSION LINE | KDJ | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 28, 1983 | K833065 | AUTOMATIC PERITONEAL DIALYSIS CYCLER | FKX | Substantially Equivalent | Travenol Laboratories, S.A. | accessdata.fda.gov |
| November 13, 1979 | K791899 | CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 | KDJ | Substantially Equivalent | Travenol Laboratories, S.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 1, 2017 | 78085 | Class II | Terminated | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 | The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Peritoneal, Automatic Delivery
- All makers of Set, Administration, For Peritoneal Dialysis, Disposable
- 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.