FDA.reportPublic FDA data

510(k) K254300

Device
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
Applicant
Anker Innovations Limited
510(k) number
K254300
Product code
HGX
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-29
Date received
2025-12-31
Regulation
884.5160
Classification name
Pump, Breast, Powered
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ezra Zeng
Address
Unit 56, 8th Floor, Tower 2, Admiralty Centre 18 Harcourt Rd. Hong Kong HK

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HGX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254244Wearable Breast Pump (Model S39)Shenzhen TPH Technology Co., Ltd.2026-05-21
K254125Electric Breast Pump (HL-3058 II Pro)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.2026-05-13
K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)Shenzhen Root Innovation Technology Co., Ltd.2026-04-29
K260239Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)Jiangxi AOV Maternity & Baby Products Co., Ltd.2026-04-22
K253510Freestyle Mini Hands-freeMedela, LLC2026-04-10
K260033Wearable Breast Pump (Model S21A)Shenzhen TPH Technology Co., Ltd.2026-04-08
K254258Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)Shenzhen Root Innovation Technology Co., Ltd.2026-04-08
K253946Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)Shenzhen Root Innovation Technology Co., Ltd.2026-04-07
K250208SPECTRA Wearable 2Uzinmedicare Co., Ltd.2026-04-06
K252744Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)Cixi Ruihong Electric Appliance Co., Ltd.2026-04-03
K252583Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)A Cute Baby, Inc.2026-03-12
K253934Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)Shenzhen Root Innovation Technology Co., Ltd.2026-03-09
K253149Motion InBra (YM-8801) wearable breast pumpMedela, LLC2026-02-13
K252422Wearable Breast Pump (Model W2)Shenzhen TPH Technology Co., Ltd.2026-02-13
K252420Wearable Breast Pump (Model W12)Shenzhen TPH Technology Co., Ltd.2026-02-13