510(k) Report

Devices descending from K140938

2 later devices reach Ostom-I Alert through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252140Heylo™ SystemColoplast Corp.20250—
+1K181643SmartBag (SmartPouch)11 Health Technologies Limited20180—