510(k) K253510

Device
Freestyle Mini Hands-free
Applicant
Medela, LLC
510(k) number
K253510
Product code
HGX
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-10
Date received
2025-11-05
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

Related Records

Applicant Contact

Contact
Jenni Vescovo
Address
1101 Corporate Dr. Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HGX

510(k)DeviceApplicantDecision date
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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
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
K251423Spectra S1 Pro; Spectra S2 ProUzinmedicare Co., Ltd.2026-02-06
K253498Pump In Style® Pro+Medela, LLC2026-01-22