FDA applicant

Darco Intl., Inc.

Washington, DC1 decision1995–19950 recalls

FDA records 1 decision for Darco Intl., Inc. (Washington, DC) in 1995: 1 510(k) clearance. All are in product code GEY (Motor, Surgical Instrument, Ac-Powered). 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 and plastic surgery panel, where it files most

How often FDA has decided Darco Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Darco Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Darco Intl., Inc.’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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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 Water Systems, Inc. 1

Darco Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Darco”