FDA 510(k) clearance · back to tracker

MODO DUO Electric Pump (B11621, B11673)

Tomy International, Inc. cleared K261782 on 2026-10-16, decision: substantially equivalent

K-number

K261782

Sponsor

Tomy International, Inc.

Device

MODO DUO Electric Pump (B11621, B11673)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-16

Product code

HGX

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5160

Official FDA record

Open K261782on 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.