510(k) Report

FDA applicant

Vantive US Healthcare, LLC

Deerfield Lake, IL2 decisions1986–20251 recall

FDA records 2 decisions for Vantive US Healthcare, LLC (Deerfield Lake, IL) from 1986 to 2025: 1 510(k) clearance and 1 original PMA approval. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and MDP (Separator For Therapeutic Purposes, Membrane…). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Vantive US Healthcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vantive US Healthcare, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision
  • MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC · 2025
  • P830063Gambro Fiber PlasmafilterVantive US Healthcare, LLC · 19861 recall

All 2 as Vantive US Healthcare, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • P830063PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without…Jan 6, 2026Class II