Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252192 | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2025-08-13 | 30 | 0 |
| K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1 | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2024-09-11 | 152 | 0 |
| K230102 | Smart double sides wearable breast pump, Electric bilateral | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | 2023-09-21 | 251 | 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