FDA applicant

Filtertek, Inc.

Hebron, IL10 decisions1989–19980 recalls

FDA records 10 decisions for Filtertek, Inc. (Hebron, IL) from 1989 to 1998: 10 510(k) clearances. Most are in product codes FIB (Protector, Transducer, Dialysis) and FPA (Set, Administration, Intravascular). Its devices cite 3 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 Filtertek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Filtertek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Filtertek, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?