eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)— 510(k) K254300
Substantially EquivalentAnker Innovations Limited
FDA 510(k) clearance K254300 for eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009), Substantially Equivalent on 2026-05-29. Applicant: Anker Innovations Limited. Device class: 2.
Summary
Anker Innovations' eufy Wearable Breast Pump record lists eleven model numbers: T600P and T6000 through T6009. The product code is HGX, powered breast pumps.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel, and it was a Traditional 510(k).
Anker filed from Hong Kong. Review took 149 calendar days (December 31, 2025 to May 29, 2026).
Clearance details
- Applicant
- Anker Innovations Limited
- 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
- Hong Kong, HK
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 Anker Innovations Limited
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.