510(k) Report

Devices descending from K220991

2 later devices reach IntelliSep test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250912IntelliSep TestCytovale, Inc.20250—
+1K250513IntelliSep Test (CV-ICG-048)Cytovale, Inc.20250—