HGX — Pump, Breast, Powered Class II

FDA Device Classification

Classification Details

Product Code
HGX
Device Class
Class II
Regulation Number
884.5160
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253510medelaFreestyle Mini Hands-freeApril 10, 2026
K254258shenzhen root innovation technology coMomcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-April 8, 2026
K260033shenzhen tph technology coWearable Breast Pump (Model S21A)April 8, 2026
K253946shenzhen root innovation technology coMomcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9April 7, 2026
K250208uzinmedicare coSPECTRA Wearable 2April 6, 2026
K252744cixi ruihong electric appliance coWearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)April 3, 2026
K252583a cute babyMini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)March 12, 2026
K253934shenzhen root innovation technology coMomcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, March 9, 2026
K252420shenzhen tph technology coWearable Breast Pump (Model W12)February 13, 2026
K253149medelaMotion InBra (YM-8801) wearable breast pumpFebruary 13, 2026
K252422shenzhen tph technology coWearable Breast Pump (Model W2)February 13, 2026
K251423uzinmedicare coSpectra S1 Pro; Spectra S2 ProFebruary 6, 2026
K253498medelaPump In Style® Pro+January 22, 2026
K253072linhejiacheng (shenzhen) e-commerce coParuu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PDecember 23, 2025
K252342guangdong youmeng electrical technology coElectric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)December 19, 2025
K252754guangdong youmeng electrical technology coWearable Electric Breast Pump (YM-8803)December 19, 2025
K251932uzinmedicare coSpectra PlatinumNovember 25, 2025
K253283shenzhen root innovation technology coMomcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP4October 29, 2025
K252629fimilla (shanghai) maternity and baby articles coElectric Breast Pump (HL-3058, F5112)October 27, 2025
K252630fimilla (shanghai) maternity and baby articles coElectric Breast Pump (HL-3060, F5113)October 27, 2025