510(k) Report

FDA applicant

Marion Health & Safety, Inc.

Mchenry, IL2 decisions1979–19800 recalls

FDA records 2 decisions for Marion Health & Safety, Inc. (Mchenry, IL) from 1979 to 1980: 2 510(k) clearances. Most are in product codes JSN (Culture Media, Propagating Transport) and JSM (Culture Media, Non-Propagating Transport). 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, microbiology panel, where it files most

How often FDA has decided Marion Health & Safety, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marion Health & Safety, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Marion Health & Safety, Inc. 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?

  • JSNCulture Media, Propagating Transport1decision
  • JSMCulture Media, Non-Propagating Transport1decision

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.

  • K800832Viral Culturette Hank's Bal. Salt Sol.Marion Health & Safety, Inc. · 19801cites it

What has FDA decided for it lately?

  • K800832Viral Culturette Hank's Bal. Salt Sol.Marion Health & Safety, Inc. · 1980
  • K792201Strep CulturetteMarion Health & Safety, Inc. · 1979

All 2 as Marion Health & Safety, Inc. →

Other applicant names beginning “Marion”

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

Marion Laboratories, Inc. 38