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)

Freestyle Mini Hands-free

K-Number: K253510 · 2026-04-10

ApplicantMedela, LLC
Decision Date2026-04-10
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Freestyle Mini Hands-free is the device name listed in this FDA 510(k) record. The listed applicant is Medela, LLC. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253510. 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 Freestyle Mini Hands-free?

Freestyle Mini Hands-free is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Medela, LLC. The 510(k) number is K253510.

When did Freestyle Mini Hands-free receive FDA 510(k) clearance?

Freestyle Mini Hands-free received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253510.

Who is the listed applicant for Freestyle Mini Hands-free?

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

What is the FDA product code for Freestyle Mini Hands-free?

The FDA product code for Freestyle Mini Hands-free is HGX.

Other records listing Medela, LLC 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.

K253149Motion InBra (YM-8801) wearable breast pumpK253498Pump In Style® Pro+K251377Magic InBraK232608Duo Hands-free Breast PumpK223388Invia® Integrated DressingK214112Invia Ease Negative Pressure Wound Therapy (NPWT) System

View all 19 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.

↑