510(k) Report

FDA applicant

Sigmamotor, Inc.

Mchenry, IL3 decisions1977–19790 recalls

FDA records 3 decisions for Sigmamotor, Inc. (Mchenry, IL) from 1977 to 1979: 3 510(k) clearances. All are in product code FRN (Pump, Infusion). 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 Sigmamotor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sigmamotor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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