Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AViTA Breast Pump

K-Number: K250129 · 2026-06-11

ApplicantAvita Corporation
Decision Date2026-06-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AViTA Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K250129. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AViTA Breast Pump?

AViTA Breast Pump is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Avita Corporation. The 510(k) number is K250129.

When did AViTA Breast Pump receive FDA 510(k) clearance?

AViTA Breast Pump received FDA 510(k) clearance on 2026-06-11, under 510(k) number K250129.

Who is the listed applicant for AViTA Breast Pump?

The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AViTA Breast Pump?

The FDA product code for AViTA Breast Pump is HGX.

Other records listing Avita Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252448AViTA Pulse Oximeter (SP61)K250765AViTA Arm Type Blood Pressure Monitor CuffK242455AViTA Pulse Oximeter (SP62B)K241852Nasal Aspirator (NS 13)K242193Arm Type Blood Pressure Monitor (BPM82)K223399AViTA Pulse Oximeter

View all 10 devices →

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑