510(k) Report

Devices descending from K150476

24 later devices reach Spectra S1Plus and Spectra S2 Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251423Spectra S1 Pro; Spectra S2 ProUzinmedicare Co., Ltd.20260—
+1K251932Spectra PlatinumUzinmedicare Co., Ltd.20251—
+1K181784Spectra S3 PlusUzinmedicare Co.20187—
+1K180075MINUET LCD, MINUET LCD ecoUnimom.Co20186—
+1K172772Freemie Independence, Freemie LibertyDao Health20170—
+1K162870CIMLRE F1 and CIMILRE S3Cimilre Co., Ltd.20174—
+2K260956Spectra Platinum MiniUzinmedicare Co., Ltd.20260—
+2K223329Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)Guangzhou Yongyi Industrial Co., Ltd.20230—
+2K221708CIMILRE Free-T2 PlusCimilre Co., Ltd.20220—
+2K221576Ameda Pearl Electric Breast PumpAmeda, Inc.20220—
+2K212564Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd.20220—
+2K201152Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd.20212—
+2K203570Mya Joy PLUS Breast PumpAmeda, Inc.20211—
+2K191208Spectra CashmereUzinmedicare Co.20191—
+2K190810OPERA, OPERA ecoUnimom.Co20195—
+3K242111VivaceUnimom.Co20251—
+3K232047VivaceUnimom.Co20240—
+3K223084MilkMate Breast PumpMilkmate Products, Inc.20231—
+3K212955Fit Pro Breast PumpHygeia II Medical Group, Inc.20220—
+3K210124Synergy Gold (SG) Portable (Models MM011450 and MM011460)Uzinmedicare Co.20210—
+3K202045imani i1Imani Co.20211—
+4K260643Cimilre Dual MaxCimilre Co., Ltd.20260—
+4K241705MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast…Milkmate Products, Inc.20240—
+4K222573imani i2Plus Breast PumpImani Co.20230—