Shenzhen Root Innovation Technology Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)June 18, 2026
K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )June 17, 2026
K253629Momcozy Nasal Aspirator (BN007)May 26, 2026
K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN00May 15, 2026
K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)April 29, 2026
K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, April 8, 2026
K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, April 7, 2026
K253934Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)March 9, 2026
K253283Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)October 29, 2025
K251394Momcozy Wearable Breast Pump (BP223)September 8, 2025
K241680Momcozy Wearable Breast Pump (BP311)December 20, 2024
K233880Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)March 6, 2024