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.
Clearance details
- Applicant
- Guangdong Horigen Mother & Baby Products Co., Ltd.
- Product code
- 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 all- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K260643 — Cimilre Dual Max
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
- K261199 — Wearable Breast Pump (Model S32A)
More 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.