FDA applicant

Msi, Inc.

Tarpon Springs, FL3 decisions1995–20224 recalls

FDA records 3 decisions for Msi, Inc. (Tarpon Springs, FL) from 1995 to 2022: 3 510(k) clearances. Most are in product codes DOX (Fluorometer, Lead (Dedicated Instruments)) and DYB (Introducer, Catheter). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Msi”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

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

FDA decisions per year

1in 2022

2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Msi, 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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Msi, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?