Wearable breast pump (Model: XN/MD-2249BS, ZFHF)— 510(k) K262774
Substantially EquivalentGuangdong Horigen Mother & Baby Products Co., Ltd.
FDA 510(k) clearance K262774 for Wearable breast pump (Model: XN/MD-2249BS, ZFHF), Substantially Equivalent on 2026-09-01. Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd.. Device class: 2.
Summary
Wearable breast pump (Model: XN/MD-2249BS, ZFHF) is from Guangdong Horigen Mother & Baby Products Co., Ltd., filed under product code HGX (Pump, Breast, Powered). The record gives the model designations and no other detail.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Horigen filed from Shantou, China. The decision came 28 calendar days after receipt (August 4 to September 1, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shantou, CN
Recent devices under product code HGX
view allMore clearances from Guangdong Horigen Mother & Baby Products Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.