Vantive US Healthcare LLC
FDA Regulatory Profile
Vantive US Healthcare LLC appears in FDA public data with 12 recalls, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1229-2026, Class II) was initiated on January 6, 2026. Its most recent 510(k) clearance was granted on August 1, 2025.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1229-2026 | Class II | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialy | January 6, 2026 |
| Z-1230-2026 | Class II | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialy | January 6, 2026 |
| Z-1228-2026 | Class II | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysa | January 6, 2026 |
| Z-1224-2026 | Class II | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed D | January 6, 2026 |
| Z-1227-2026 | Class II | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysa | January 6, 2026 |
| Z-1225-2026 | Class II | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed D | January 6, 2026 |
| Z-1231-2026 | Class II | PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dial | January 6, 2026 |
| Z-1226-2026 | Class II | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System | January 6, 2026 |
| Z-0409-2026 | Class II | Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software ve | August 28, 2025 |
| Z-2437-2025 | Class II | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 | July 28, 2025 |
| Z-2438-2025 | Class II | PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 | July 28, 2025 |
| Z-2439-2025 | Class II | TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 | July 28, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250508 | AK 98 Dialysis Machine (955607) | August 1, 2025 |