Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Guangdong Horigen Mother & Baby Products Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
370 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212564 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2022-05-06 | 266 | 0 |
| K201152 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021-05-04 | 370 | 0 |
| K201974 | Single-use medical face mask | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021-03-07 | 235 | 0 |
| K193449 | Electric Breast Pump (model KP033_01), Electric Double Breas | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2020-09-11 | 273 | 0 |
| K182413 | Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2019-03-07 | 184 | 0 |
| K162747 | Proture Double Electric Breast Pump | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2016-12-08 | 69 | 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