Guangdong Horigen Mother & Baby Products Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Guangdong Horigen Mother & Baby Products Co., Ltd.” (first 2016, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 235 days. Since 2017 the median was 250 days, against 146 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 69 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 184 |
| 2020 | 1 | 273 |
| 2021 | 2 | 302 |
| 2022 | 1 | 266 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 28 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangdong Horigen Mother & Baby Products Co., Ltd. took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 6 | 6 |
| FXX | Mask, Surgical | 1 | 1 |
Review panels
Most recent Guangdong Horigen Mother & Baby Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | HGX | 2026-09-01 | 28 |
| K212564 | Electric Breast Pump | HGX | 2022-05-06 | 266 |
| K201152 | Electric Breast Pump | HGX | 2021-05-04 | 370 |
| K201974 | Single-use medical face mask | FXX | 2021-03-07 | 235 |
| K193449 | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | HGX | 2020-09-11 | 273 |
| K182413 | Electric Breast Pump | HGX | 2019-03-07 | 184 |
| K162747 | Proture Double Electric Breast Pump | HGX | 2016-12-08 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Horigen Mother & Baby Products Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Guangdong Biolight Meditech Co., Ltd. (21 510(k)s)
- Guangdong Transtek Medical Electronics Co., Ltd. (17 510(k)s)
- Guangdong Kingfa Sci. & Tech.Co., Ltd. (14 510(k)s)
- Guangdong Optomedic Technologies, Inc. (9 510(k)s)
- Guangdong Genial Technology Co., Ltd. (5 510(k)s)
- Guangdong Newdermo Biotech Co., Ltd. (5 510(k)s)
- Guangdong Jinme Medical Technology Co., Ltd. (4 510(k)s)
- Guangdong Prestige Technology Co., Ltd. (4 510(k)s)
- Guangdong Youmeng Electrical Technology Co., Ltd. (4 510(k)s)
- Guangdong Gymda Medical Technology Co.,Ltd (2 510(k)s)
- Guangdong Kaiyang Medical Technology Co., Ltd. (2 510(k)s)
- Guangdong Xinyu Electronic and Technology Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangdong Horigen Mother & Baby Products Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Guangdong Horigen Mother & Baby Products Co., Ltd.” (first 2016, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Guangdong Horigen Mother & Baby Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangdong Horigen Mother & Baby Products Co., Ltd. is 235 days. Since 2017: 250 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangdong Horigen Mother & Baby Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 6); FXX (Mask, Surgical, 1).
Next steps
- See all 7 Guangdong Horigen Mother & Baby Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Guangdong Horigen Mother & Baby Products Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.