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FDA 510(k)

Motion InBra (YM-8801) wearable breast pump

K-Number: K253149 · 2026-02-13

ApplicantMedela, LLC
Decision Date2026-02-13
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Motion InBra (YM-8801) wearable breast pump is a medical device manufactured by Medela, LLC. It received FDA 510(k) clearance on 2026-02-13 under approval number K253149. 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 Motion InBra (YM-8801) wearable breast pump?

Motion InBra (YM-8801) wearable breast pump is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Medela, LLC. The 510(k) number is K253149.

When was Motion InBra (YM-8801) wearable breast pump approved by the FDA?

Motion InBra (YM-8801) wearable breast pump received FDA 510(k) clearance on 2026-02-13, under approval number K253149.

What company makes Motion InBra (YM-8801) wearable breast pump?

Motion InBra (YM-8801) wearable breast pump is manufactured by Medela, LLC.

What is the FDA product code for Motion InBra (YM-8801) wearable breast pump?

The FDA product code for Motion InBra (YM-8801) wearable breast pump is HGX.

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Other Devices by Medela, LLC

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Related Devices (Code: HGX)

K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc. K160274Hi bebe plusBistos Co., Ltd. K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven K161266Athena Breast PumpExploramed Nc7, Inc. K160511Naya Breast Pump SystemNaya Health, Inc.

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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