Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251977 | electric breast pump (FZ-P8); electric breast pump (YH-P8); | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-10-22 | 117 | 0 |
| K242725 | Youha electric breast pumps (The INs, The INs Gen2, The INs | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2025-05-30 | 262 | 0 |
| K203148 | Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-801 | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2021-07-08 | 259 | 0 |
| K163136 | Youha electric breast pump | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | 2017-07-31 | 265 | 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