# Guangdong Horigen Mother & Baby Products Co., Ltd.

- Location (FDA's records): Shantou, CN
- FDA decisions: 7 (2016–2026): 7 510(k) clearances
- Product codes: HGX (6), FXX (1)
- 510(k) review time since 2016: median 235 days, against 158 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Uzinmedicare Co.: 2 (https://510kreport.com/company/uzinmedicare)
- Naya Health, Inc.: 1 (https://510kreport.com/company/naya-health)
- Shantou Xinghe Electrical Apparatuses Co., Ltd.: 1 (https://510kreport.com/company/shantou-xinghe-electrical-apparatuses)
- Protect U Guard, LLC: 1 (https://510kreport.com/company/protect-u-guard)
- Shenzhen TPH Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-tph-technology)

## Firms that cite its devices most
- Milkmate Products, Inc.: 1 (https://510kreport.com/company/milkmate-products)

## Its most-cited devices
- K201152: Electric Breast Pump (2021), cited by 1
- K182413: Electric Breast Pump (2019), cited by 1

## Recent decisions
- K262774: Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
- K212564: Electric Breast Pump (May 6, 2022)
- K201152: Electric Breast Pump (May 4, 2021)
- K201974: Single-use medical face mask (Mar 7, 2021)
- K193449: Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) (Sep 11, 2020)
- K182413: Electric Breast Pump (Mar 7, 2019)
- K162747: Proture Double Electric Breast Pump (Dec 8, 2016)

Source page: https://510kreport.com/company/guangdong-horigen-mother-baby-products