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
FDA 510(k) Regulatory Record - Shenzhen Root Innovation Technology Co., Ltd. Obstetrics & Gynecology ✕
11 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
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