FDA applicant
Sigmamotor, Inc.
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
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.
Planning a device like Sigmamotor, 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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