510(k) Report

FDA applicant

Sterilogic Waste Systems, Inc.

Kempton, PA2 decisions1999–20020 recalls

FDA records 2 decisions for Sterilogic Waste Systems, Inc. (Kempton, PA) from 1999 to 2002: 2 510(k) clearances. All are in product code MMK (Container, Sharps). Its devices cite 3 predicates, 1 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 Sterilogic Waste Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterilogic Waste Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sterilogic Waste Systems, 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?

  • MMKContainer, Sharps2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K020664Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 20022cite it
  • K991612Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 19991cites it

What has FDA decided for it lately?

  • K020664Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
  • K991612Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999

All 2 as Sterilogic Waste Systems, Inc. →