Cleared Traditional

K262774 - Wearable breast pump (Model: XN/MD-2249BS, ZFHF)

K262774 is an FDA 510(k) clearance for Wearable breast pump (Model: XN/MD-2249BS, manufactured by Guangdong Horigen Mother & Baby Products Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K262774 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
28d
Days
Class 2
Risk

K262774 is an FDA 510(k) clearance for the Wearable breast pump (Model: XN/MD-2249BS, ZFHF). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. (Shantou, CN). The FDA issued a Cleared decision on September 1, 2026 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guangdong Horigen Mother & Baby Products Co., Ltd. devices

FDA 510(k) Submission Details - K262774

510(k) Number K262774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2026
Decision Date September 01, 2026
Days to Decision 28 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 161d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 227
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K262774.
Wearable Breast Pump (Model S36)
K254203 · Shenzhen TPH Technology Co., Ltd. · Sep 2026
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62)
K261622 · Philips Consumer Lifestyle B.V. · Sep 2026
Cimilre Dual Max
K260643 · Cimilre Co., Ltd. · Aug 2026
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
K261298 · Guangdong Youmeng Electrical Technology Co., Ltd. · Aug 2026
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Wearable Breast Pump (Model S32A)
K261199 · Shenzhen TPH Technology Co., Ltd. · Jul 2026

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.