510(k) Report

FDA applicant

Steri-Sytems, Corp.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Steri-Sytems, Corp. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code KPE (Container, I.V.). 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 Steri-Sytems, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Steri-Sytems, Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KPEContainer, I.V.1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K830232Decanter Models-VariousSteri-Sytems, Corp. · 19831cites it

What has FDA decided for it lately?

  • K830232Decanter Models-VariousSteri-Sytems, Corp. · 1983

The one decision as Steri-Sytems, Corp. →

Other applicant names beginning “Steri-Sytems”

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

Steri-Oss, Inc. 46Steri-Shield Products, Inc. 5Steri-Sol, Inc. 1Steri-Aid, Inc. 1