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510(k) K250129

AViTA Breast Pump by Avita Corporation — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
January 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

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  • K172427 — AViTA Radar Thermo NT16 Series IR Thermometer (April 19, 2018)
  • K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITOR (January 18, 2012)

Other clearances for product code HGX

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  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (June 9, 2026)
  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)
  • K254125 — Electric Breast Pump (HL-3058 II Pro) (May 13, 2026)
  • K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, (April 29, 2026)
  • K260239 — Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) (April 22, 2026)