510(k) Report

FDA applicant

Summa Medical Corp.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Summa Medical Corp. (Mchenry, IL) in 1984: 1 510(k) clearance. No recall is linked to its devices.

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

How often FDA has decided Summa Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Summa Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Summa”

FDA records each applicant name separately; these may or may not be the same firm.