510(k) Report

Devices descending from K850289

11 later devices reach Monarch Sterilization Container System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041623Reusable Sterilcontainer Filter Model #JK090Aesculap, Inc.200410—
+2K073168Aesculap Primeline Container LTD.Aesculap, Inc.20089—
+3K172850SterilContainer with PrimeLine Pro LidAesculap, Inc.20170—
+3K112671Sterilcontainer SystemAesculap, Ltd.20127—
+4K192056JJ Series Container SystemAesculap, Inc.20205—
+4K193582SterilContainer S2 SystemAesculap, Inc.20200—
+5K214041Aesculap AICON ContainerAesculap, Inc.20224—
+6K242762Aesculap Aicon® Series Container SystemAesculap, Inc.20250—
+6K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies20250—
+6K242834System 9 Sterile Battery ContainerStryker Instruments20250—
+6K233578Bahadir Sterilization ContainersBahadir USA, LLC20240—