Data / Medical devices / India / Vantive Healthcare Technologies Private Limited
Vantive Healthcare Technologies Private Limited: FDA-registered device maker in Bangalore Karnataka, India, 16 510(k) clearances
Vantive Healthcare Technologies Private Limited is registered with the FDA (registration 3032828299) in Bangalore Karnataka, India. It lists 7 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 1, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3032828299
- Address
- Tower B, 16th Floor Prestige Shantiniketan, Bangalore, Bangalore Karnataka, India, 560048
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Specification developer
- First device listed
- September 27, 1983
- Registered through
- 2026
- Brand names listed
- 12 ft Extension Set, 3L Ultra Set CAPD Disposable Y-Set, AK 98 Dialysis Machine, Amia Automated PD System with Sharesource, Automated Dialysis Cycler System, Automated PD Set with Cassette 4-Prong, BICART, Baxter 12' Extension Line and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Hemoperfusion, Sorbent | FLD | 2 | Specification developer | accessdata.fda.gov |
| Clamp, Line | FKK | 1 | Specification developer | accessdata.fda.gov |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | 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, Hemodialysis, Remote Accessories | MON | 1 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| November 19, 2020 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | FKX | 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 |
| January 6, 2017 | K162887 | PrismaSATE | KPO | 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 26, 2014 | K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | FLD | Substantially Equivalent | Gambro Renal Products, Inc. | 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 |
| February 4, 2008 | K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | KPO | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| January 8, 2002 | K013724 | BICART | KPO | Substantially Equivalent | Gambro Renal Products | 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 |
Compare with other makers
- All makers of Set, Administration, For Peritoneal Dialysis, Disposable
- All makers of Apparatus, Hemoperfusion, Sorbent
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of System, Peritoneal, Automatic Delivery
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- All makers of Clamp, Line
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.