Cleared Traditional

K261782 - MODO DUO Electric Pump (B11621, B11673)

K261782 is an FDA 510(k) clearance for MODO DUO Electric Pump (B11621, manufactured by Tomy International, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K261782 · Tomy International, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
140d
Days
Class 2
Risk

K261782 is an FDA 510(k) clearance for the MODO DUO Electric Pump (B11621, B11673). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Tomy International, Inc. (Dyersville, US). The FDA issued a Cleared decision on October 16, 2026 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K261782

510(k) Number K261782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2026
Decision Date October 16, 2026
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 161d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 254
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K261782.
Nenesupply Venus Handsfree Breast Pump (NBP001-HF)
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K261298 · Guangdong Youmeng Electrical Technology Co., Ltd. · Aug 2026
K261782 · MODO DUO Electric Pump (B11621, B11673)
Download PDF FDA Summary Tomy International, I…