Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Lutejiacheng Technology 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) |
|---|---|---|---|---|---|
| K230776 | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 P | Shenzhen Lutejiacheng Technology Co., Ltd. | 2023-06-09 | 80 | 0 |
| K223693 | Electric breast pump (model: M5) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2023-03-09 | 90 | 0 |
| K220309 | Wearable Breast Pump (Model S10) | Shenzhen Lutejiacheng Technology Co., Ltd. | 2022-06-27 | 145 | 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