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FDA 510(k)

MODO DUO Electric Pump (B11621, B11673)

K-Number: K261782 · 2026-10-16

ApplicantTomy International, Inc.
Decision Date2026-10-16
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODO DUO Electric Pump (B11621, B11673) is the device name listed in this FDA 510(k) record. The listed applicant is Tomy International, Inc.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K261782. 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 MODO DUO Electric Pump (B11621, B11673)?

MODO DUO Electric Pump (B11621, B11673) is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Tomy International, Inc.. The 510(k) number is K261782.

When did MODO DUO Electric Pump (B11621, B11673) receive FDA 510(k) clearance?

MODO DUO Electric Pump (B11621, B11673) received FDA 510(k) clearance on 2026-10-16, under 510(k) number K261782.

Who is the listed applicant for MODO DUO Electric Pump (B11621, B11673)?

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

What is the FDA product code for MODO DUO Electric Pump (B11621, B11673)?

The FDA product code for MODO DUO Electric Pump (B11621, B11673) is HGX.

Related Clinical Trials

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.

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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.

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH 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.

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