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
K254254shenzhen root innovation technology coMomcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)June 18, 2026
K260538shenzhen root innovation technology coMomcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )June 17, 2026
K260346polybell (guangzhou) limitedElectric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11June 12, 2026
K250129avita corporationAViTA Breast PumpJune 11, 2026
K260864shenzhen tph technology coMother's Nature W1 Warming Wearable Breast PumpJune 9, 2026
K260956uzinmedicare coSpectra Platinum MiniJune 4, 2026
K254300anker innovations limitedeufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600May 29, 2026
K254244shenzhen tph technology coWearable Breast Pump (Model S39)May 21, 2026
K254125fimilla (shanghai) maternity and baby articles coElectric Breast Pump (HL-3058 II Pro)May 13, 2026
K253914shenzhen root innovation technology coMomcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, April 29, 2026
K260239jiangxi aov maternity and baby products coWearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)April 22, 2026
K253510medelaFreestyle Mini Hands-freeApril 10, 2026
K260033shenzhen tph technology coWearable Breast Pump (Model S21A)April 8, 2026
K254258shenzhen root innovation technology coMomcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-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
K252422shenzhen tph technology coWearable Breast Pump (Model W2)February 13, 2026