510(k) Report

FDA applicant

Baxter Healthcare Corporation - Renal Division

Mcgaw Park, IL2 decisions2010–20120 recalls

FDA records 2 decisions for Baxter Healthcare Corporation - Renal Division (Mcgaw Park, IL) from 2010 to 2012: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KDI (Dialyzer, High Permeability With Or Without…). Its devices cite 4 predicates, 0 of them its own earlier devices. No 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, general hospital panel, where it files most

How often FDA has decided Baxter Healthcare Corporation - Renal Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Baxter Healthcare Corporation - Renal Division by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baxter Healthcare Corporation - Renal…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 20122cite it
  • K093120Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170Baxter Healthcare Corporation - Renal Division · 20101cites it

What has FDA decided for it lately?

  • K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 2012
  • K093120Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150, Xenium XPM 170Baxter Healthcare Corporation - Renal Division · 2010

All 2 as Baxter Healthcare Corporation - Renal Division →

Other applicant names beginning “Baxter”

FDA records each applicant name separately; these may or may not be the same firm.

Baxter Healthcare Corp 574Baxter Diagnostics, Inc. 72Baxter Edwards 11Baxter Bentley Laboratories, Inc. 3Baxter Healthcare Corportation 3Baxter/ Synovis Micro Companies Alliance, Inc. 2Baxter Healthcare Corp/ Excel Medical 1Baxter Centre For Medical Research 1Baxter Healthcare Corproration 1Baxter Corp. 1Baxter Interwoven Offsite 1Baxter Healthcare Corp., Bioscience 1