510(k) Report

FDA applicant

Baxter Healthcare Corportation

Round Lake, IL3 decisions2020–20241 recall

FDA records 3 decisions for Baxter Healthcare Corportation (Round Lake, IL) from 2020 to 2024: 3 510(k) clearances. Most are in product codes BYI (Percussor, Powered-Electric) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 5 predicates, 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 Baxter Healthcare Corportation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12021: 12024: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2020high 1 (2021) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Baxter Healthcare Corportation by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Baxter Healthcare Corportation’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?

  • BYIPercussor, Powered-Electric1decision
  • GCJLaparoscope, General & Plastic Surgery1decision
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation · 20212cite it

What has FDA decided for it lately?

  • K233441The Vest APX System (PVAPX1)Baxter Healthcare Corportation · 2024
  • K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation · 2021
  • K193137EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation · 20201 recall

All 3 as Baxter Healthcare Corportation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K193137EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.Jun 15, 2021Class II

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 Corporation - Renal Division 2Baxter/ 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