FDA 510(k) clearance · back to tracker

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Guangdong Youmeng Electrical Technology Co., Ltd. cleared K261298 on 2026-08-20, decision: substantially equivalent

K-number

K261298

Sponsor

Guangdong Youmeng Electrical Technology Co., Ltd.

Device

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-08-20

Product code

HGX

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5160

Official FDA record

Open K261298on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.