510(k) Report

FDA applicant

Hospal Industrie

Arvada, CO1 decision2001–20010 recalls

FDA records 1 decision for Hospal Industrie (Arvada, CO) in 2001: 1 510(k) clearance. All are in product code KDI (Dialyzer, High Permeability With Or Without…). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Hospal Industrie’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hospal Industrie since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hospal Industrie 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

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K003023Cobe HC 700 Midi HemoconcentratorHospal Industrie · 20011cites it

What has FDA decided for it lately?

  • K003023Cobe HC 700 Midi HemoconcentratorHospal Industrie · 2001

The one decision as Hospal Industrie →

Other applicant names beginning “Hospal”

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

Hospal Medical Corp. 55Hospal 1