Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Root Innovation Technology Co., Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
188 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-18 | 171 | 0 |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-06-17 | 120 | 0 |
| K253629 | Momcozy Nasal Aspirator (BN007) | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-26 | 188 | 0 |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN00 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-05-15 | 119 | 0 |
| K253914 | Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-29 | 142 | 0 |
| K254258 | Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-08 | 100 | 0 |
| K253946 | Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-04-07 | 118 | 0 |
| K253934 | Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380 | Shenzhen Root Innovation Technology Co., Ltd. | 2026-03-09 | 90 | 0 |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, | Shenzhen Root Innovation Technology Co., Ltd. | 2025-10-29 | 30 | 0 |
| K251394 | Momcozy Wearable Breast Pump (BP223) | Shenzhen Root Innovation Technology Co., Ltd. | 2025-09-08 | 126 | 0 |
| K241680 | Momcozy Wearable Breast Pump (BP311) | Shenzhen Root Innovation Technology Co., Ltd. | 2024-12-20 | 192 | 0 |
| K243629 | Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breas | Shenzhen Root Innovation Technology Co., , Ltd. | 2024-12-20 | 25 | 0 |
| K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breas | Shenzhen Root Innovation Technology Co., Ltd. | 2024-03-06 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda