FDA applicant

Darco Water Systems, Inc.

Walker, MI1 decision1980–19800 recalls

FDA records 1 decision for Darco Water Systems, Inc. (Walker, MI) in 1980: 1 510(k) clearance. All are in product code FIP (Subsystem, Water Purification). 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 Darco Water Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Darco Water Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Darco”

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

Darco International, Inc. 2 Darco Intl., Inc. 1

Darco Water Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Darco”