FDA applicant

Fluidsense Corp.

Newburyport, MA2 decisions1998–20000 recalls

FDA records 2 decisions for Fluidsense Corp. (Newburyport, MA) from 1998 to 2000: 2 510(k) clearances. All are in product code FRN (Pump, Infusion). 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 Fluidsense Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fluidsense Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Fluidsense Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?