510(k) Report

FDA applicant

Oak Ridge Products, LLC

Mchenry, IL3 decisions2013–20160 recalls

FDA records 3 decisions for Oak Ridge Products, LLC (Mchenry, IL) from 2013 to 2016: 3 510(k) clearances. All are in product code MMK (Container, Sharps). Its devices cite 5 predicates, 2 of them its own earlier devices. 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 Oak Ridge Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12014: 12016: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Oak Ridge Products, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MMKContainer, Sharps3decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 20134cite it
  • K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 20161cites it

What has FDA decided for it lately?

  • K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
  • K141759Oak Ridge Products Multi-Purpose Sharps ContainersOak Ridge Products, LLC · 2014
  • K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013

All 3 as Oak Ridge Products, LLC →