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The Tracker / October 2026 / K261782

510(k) cleared

MODO DUO Electric Pump (B11621, B11673)

Tomy International, Inc. · Oct 16, 2026 · K261782

FDA cleared the MODO DUO Electric Pump (B11621, B11673) from Tomy International, Inc. on Oct 16, 2026 under K261782, a traditional 510(k). The device falls under product code HGX, Pump, Breast, Powered, regulated at 21 CFR 884.5160 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on May 29, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Tomy International, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261782?

K261782 is the FDA 510(k) for MODO DUO Electric Pump (B11621, B11673), submitted by Tomy International, Inc.. FDA's decision date was Oct 16, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the MODO DUO Electric Pump (B11621, B11673)?

Tomy International, Inc., based in Dyersville, IA, is the applicant of record for K261782.

How long did the K261782 review take?

FDA received the submission on May 29, 2026 and issued its decision on Oct 16, 2026, 140 days later.

← All decisions in October 2026