510(k) Report

Devices descending from K190810

5 later devices reach OPERA, OPERA eco through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242111VivaceUnimom.Co20251—
+1K232047VivaceUnimom.Co20240—
+1K202045imani i1Imani Co.20211—
+2K260643Cimilre Dual MaxCimilre Co., Ltd.20260—
+2K222573imani i2Plus Breast PumpImani Co.20230—