ClearanceBrief
Company ยท US

VANTIVE US HEALTHCARE LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2025 to 2025. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
12recalls (8 in 12 months)
10recalls that name a 510(k)

Product codes

CodeDeviceRecords
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System11
FKXSystem, Peritoneal, Automatic Delivery1
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 1, 2025K250508AK 98 Dialysis Machine (955607)
Vantive US Healthcare, LLC
KDI

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 MDPNone listed
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDIK042938
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDIK042938
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDIK080519
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDIK041005
Feb 2, 2026VANTIVE US HEALTHCARE LLC
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDINone listed
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDIK212216
Feb 2, 2026VANTIVE US HEALTHCARE LLC
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Open, Classified		 KDIK212216
Oct 29, 2025Vantive US Healthcare LLC
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Open, Classified		 FKXK201867
Aug 26, 2025VANTIVE US HEALTHCARE LLC
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Open, Classified		 KDIK190910
K193482
Aug 26, 2025VANTIVE US HEALTHCARE LLC
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Open, Classified		 KDIK193482
Aug 26, 2025VANTIVE US HEALTHCARE LLC
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Open, Classified		 KDIK190910
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