Company · CN
Shenzhen Root Innovation Technology Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (8 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 2026 | K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Jun 17, 2026 | K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| May 26, 2026 | K253629 | Momcozy Nasal Aspirator (BN007) Shenzhen Root Innovation Technology Co., Ltd., CN | BTA |
| May 15, 2026 | K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021 Shenzhen Root Innovation Technology Co., Ltd., CN | BTA |
| Apr 29, 2026 | K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Apr 8, 2026 | K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Apr 7, 2026 | K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Mar 9, 2026 | K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Oct 29, 2025 | K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Sep 8, 2025 | K251394 | Momcozy Wearable Breast Pump (BP223) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Dec 20, 2024 | K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcoz Shenzhen Root Innovation Technology Co., , Ltd., CN | HGX |
| Dec 20, 2024 | K241680 | Momcozy Wearable Breast Pump (BP311) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
| Mar 6, 2024 | K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) Shenzhen Root Innovation Technology Co., Ltd., CN | HGX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||