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FDA 510(k)

Magic InBra

K-Number: K251377 · 2025-09-18

ApplicantMedela AG
Decision Date2025-09-18
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Magic InBra is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K251377. 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 Magic InBra?

Magic InBra is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is Medela AG. The 510(k) number is K251377.

When did Magic InBra receive FDA 510(k) clearance?

Magic InBra received FDA 510(k) clearance on 2025-09-18, under 510(k) number K251377.

Who is the listed applicant for Magic InBra?

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

What is the FDA product code for Magic InBra?

The FDA product code for Magic InBra is HGX.

Other records listing Medela AG 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.

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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.

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