Shenzhen Root Innovation Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Shenzhen Root Innovation Technology Co., Ltd.” (first 2024, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 120 days. Since 2017 the median was 120 days, against 147 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 2 | 140 |
| 2025 | 2 | 78 |
| 2026 | 8 | 120 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Root Innovation Technology Co., Ltd. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 10 | 10 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
Review panels
Most recent Shenzhen Root Innovation Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) | HGX | 2026-06-18 | 171 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) | HGX | 2026-06-17 | 120 |
| K253629 | Momcozy Nasal Aspirator (BN007) | BTA | 2026-05-26 | 188 |
| 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) | BTA | 2026-05-15 | 119 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | HGX | 2026-04-29 | 142 |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) | HGX | 2026-04-08 | 100 |
| 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, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | HGX | 2026-04-07 | 118 |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) | HGX | 2026-03-09 | 90 |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) | HGX | 2025-10-29 | 30 |
| K251394 | Momcozy Wearable Breast Pump (BP223) | HGX | 2025-09-08 | 126 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Root Innovation Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
- Shenzhen Kentro Medical Electronics Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Root Innovation Technology Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Shenzhen Root Innovation Technology Co., Ltd.” (first 2024, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Root Innovation Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Root Innovation Technology Co., Ltd. is 120 days. Since 2017: 120 days, versus 147 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Root Innovation Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 10); BTA (Pump, Portable, Aspiration (Manual Or Powered), 2).
Next steps
- See all 12 Shenzhen Root Innovation Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Shenzhen Root Innovation Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.