Nenesupply Venus Handsfree Breast Pump (NBP001-HF)— 510(k) K262125

Name: FDA 510(k) clearance K262125
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Nenesupply Co., Ltd.

FDA 510(k) clearance K262125 for Nenesupply Venus Handsfree Breast Pump (NBP001-HF), Substantially Equivalent on 2026-10-29. Applicant: Nenesupply Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nenesupply Co., Ltd.
Product code: Product code HGX
Device class: Class 2
Regulation: 21 CFR 884.5160
Advisory panel: Obstetrics/Gynecology
Date received: 2026-06-24
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGX

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K261782 — MODO DUO Electric Pump (B11621, B11673)2026-10-16
K254203 — Wearable Breast Pump (Model S36)2026-09-17
K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more2026-09-03
K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)2026-09-01
K260643 — Cimilre Dual Max2026-08-21

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.