Shenzhen Root Innovation Technology Co., Ltd. is one of 2114 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shenzhen Root Innovation Technology Co., Ltd. - FDA 510(k) Cleared De...
Recent clearances: Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D), Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ), Momcozy Nasal Aspirator (BN007)
13
Total
13
Cleared
0
Denied
Shenzhen Root Innovation Technology Co., Ltd. has 13 FDA 510(k) cleared obstetrics & gynecology devices. Based in Shenzhen, CN.
Latest FDA clearance: Jun 2026. Active since 2024.
Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Shenzhen Reanny Medical Devices Management Consulting Co., Ltd., Shanghai Truthful Information Technology Co., Ltd. and Shenzhen Root Innovation Technology Co., , Ltd..
FDA 510(k) Regulatory Record - Shenzhen Root Innovation Technology Co., Ltd.
13 devices
Cleared
Jun 18, 2026
Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
Obstetrics & Gynecology
171d
Cleared
Jun 17, 2026
Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
Obstetrics & Gynecology
120d
Cleared
May 26, 2026
Momcozy Nasal Aspirator (BN007)
Ear, Nose, Throat
188d
Cleared
May 15, 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
Ear, Nose, Throat
119d
Cleared
Apr 29, 2026
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C,...
Obstetrics & Gynecology
142d
Cleared
Apr 08, 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D,...
Obstetrics & Gynecology
100d
Cleared
Apr 07, 2026
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D,...
Obstetrics & Gynecology
118d
Cleared
Mar 09, 2026
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A,...
Obstetrics & Gynecology
90d
Cleared
Oct 29, 2025
Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-,...
Obstetrics & Gynecology
30d
Cleared
Sep 08, 2025
Momcozy Wearable Breast Pump (BP223)
Obstetrics & Gynecology
126d
Cleared
Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
Obstetrics & Gynecology
192d
Cleared
Dec 20, 2024
Momcozy Wearable Breast Pump (BP311)
Obstetrics & Gynecology
25d
Cleared
Mar 06, 2024
Momcozy Wearable Breast Pump (BP137)
Obstetrics & Gynecology
89d