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510(k) K250129

AViTA Breast Pump by Avita Corporation — Product Code HGX

K250129 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AViTA Breast Pump". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Avita Corporation has at least 10 other 510(k) clearances on record.

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

Other clearances by Avita Corporation

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K250765 — AViTA Arm Type Blood Pressure Monitor Cuff (September 3, 2025)
  • K242455 — AViTA Pulse Oximeter (SP62B) (February 19, 2025)
  • K241852 — Nasal Aspirator (NS 13) (December 31, 2024)
  • K242193 — Arm Type Blood Pressure Monitor (BPM82) (October 22, 2024)
  • K223399 — AViTA Pulse Oximeter (May 20, 2024)
  • K200346 — Wrist Type Blood Pressure Monitor (December 17, 2020)
  • K180155 — Arm Type Blood Pressure Monitor (August 3, 2018)
  • 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

  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 (June 12, 2026)
  • 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)

FDA data resources