510(k) Report

Devices descending from K161020

4 later devices reach XSTAT-12, 3-Pack, XSTAT-12, 1-Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170334XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 PackRevmedx, Inc.20173—
+2K180051XSTAT 30, 1-PackRevmedx, Inc.20182—
+3K210676XSTAT 30 PouchRevmedx, Inc.20211—
+4K253290Xstat P15Revmedx, Inc.20250—