Chrysalis Intelligence · Sponsors · Vantive US Healthcare, LLC

Vantive US Healthcare, LLC

Deerfield Lake, IL, US · 1 510(k) clearances · 18 PMAs · 12 recalls

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Total clearances
1
2025-08-01 → 2025-08-01
Last 12 months
0
Product codes
1
Most recent
2025-08-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II Gastroenterology, Urology 1 2025-08-01
Class III

PMA approvals (18)

Total PMA records
18
Originals + supplements
Distinct product codes
1
First decision
2020-03-25
Most recent
2026-07-15
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-15 P830063-S032 PRISMAFLEX TPE2000 SET 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2026-03-13 P830063-S030 Prismaflex TPE2000 Set Real-Time Process MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2025-12-23 P830063-S031 Gambro Prismaflex TPE 2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2024-12-06 P830063-S029 Gambro Prismaflex TPE 2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2024-10-24 P830063-S028 Gambro Prismaflex TPE 2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2024-01-10 P830063-S027 Prismaflex TPE2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2023-10-27 P830063-S026 Gambro Prismaflex TPE 2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2023-03-29 P830063-S025 Prismaflex TPE2000 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2022-11-08 P830063-S024 Gambro Prismaflex TPE 2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2022-04-07 P830063-S023 Gambro Prismaflex TPE 2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2022-03-31 P830063-S022 PRISMAFLEX TPE2000 SET 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2022-01-27 P830063-S020 Gambro Prismaflex TPE 2000 Set Real-Time Process MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2021-07-16 P830063-S018 Prismaflex TPE2000 Set Real-Time Process MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2021-06-24 P830063-S019 Prismaflex TPE2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2021-02-12 P830063-S013 Prismaflex TPE2000 Set Real-Time Process MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2020-08-27 P830063-S017 Gambro Prismaflex TPE2000 Set 30-Day Notice MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2020-05-23 P830063-S016 PRISMAFLEX TPE 2000 Set Real-Time Process MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
2020-03-25 P830063-S015 Prismaflex TPE2000 Set Special (Immediate Track) MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown
Safety

Recalls (12)

Class I (serious)
0
Risk of injury / death
Total recalls
12
Currently ongoing
12
Most recent
2026-01-06
DateSeverityStatusRecall # ProductCodeReason
2026-01-06 Class II Ongoing Z-1231-2026 PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1230-2026 PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1229-2026 PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1228-2026 PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1227-2026 PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1226-2026 OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1225-2026 PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06 Class II Ongoing Z-1224-2026 PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System — There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2025-08-28 Class II Ongoing Z-0409-2026 Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China… — Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be pro…
2025-07-28 Class II Ongoing Z-2439-2025 TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 — Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm …
2025-07-28 Class II Ongoing Z-2438-2025 PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 — Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to Pr…
2025-07-28 Class II Ongoing Z-2437-2025 PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 — Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2025-08-01 K250508 AK 98 Dialysis Machine (955607) KDI Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-02 09:37 · Last ingest 2026-08-02T13:37:48.816939 · Pipeline: Chrysalis Intelligence