Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)— 510(k) K260239
Substantially EquivalentJiangxi AOV Maternity & Baby Products Co., Ltd.
FDA 510(k) clearance K260239 for Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862), Substantially Equivalent on 2026-04-22. Applicant: Jiangxi AOV Maternity & Baby Products Co., Ltd.. Device class: 2.
Summary
Jiangxi AOV Maternity & Baby Products' Wearable Breast Pump is filed under product code HGX (Pump, Breast, Powered). The name lists four models: AOV6853, AOV6860, AOV6861, and AOV6862.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Jiangxi AOV Maternity & Baby Products filed from Guixi, China. The record shows 86 calendar days from receipt to decision (January 26 to April 22, 2026).
Clearance details
- Applicant
- Jiangxi AOV Maternity & 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
- Guixi, CN
Recent devices under product code HGX
view all- K262125 — Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
- K261782 — MODO DUO Electric Pump (B11621, B11673)
- K254203 — Wearable Breast Pump (Model S36)
- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
More clearances from Jiangxi AOV Maternity & 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.