Cleared Traditional

K250368 - Wearable Breast Pump (Model S21)

K250368 is an FDA 510(k) clearance for Wearable Breast Pump (Model S21), manufactured by Shenzhen TPH Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K250368 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
109d
Days
Class 2
Risk

K250368 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S21). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Shenzhen TPH Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 30, 2025 after a review of 109 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.

View all Shenzhen TPH Technology Co., Ltd. devices

FDA 510(k) Submission Details - K250368

510(k) Number K250368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2025
Decision Date May 30, 2025
Days to Decision 109 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
51d faster than avg
Panel avg: 160d · This submission: 109d
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 Peers - HGX Pump, Breast, Powered

All 135
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K250368.
Thrive 2-in-1 Breast Pump (Model P3)
K250350 · Shenzhen TPH Technology Co., Ltd. · Jul 2025
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
K242725 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · May 2025
Motif Aura Glow breast pump (Model Motif Aura Glow)
K250365 · Shenzhen TPH Technology Co., Ltd. · May 2025
Wearable breast pump (model S12A)
K243508 · Shenzhen TPH Technology Co., Ltd. · Apr 2025
Lacevo Wearable Breast Pump (Model S70)
K250829 · Shenzhen TPH Technology Co., Ltd. · Apr 2025
eufy Wearable Breast Pump S1 (T8D02) Model T8D02
K250152 · Shenzhen TPH Technology Co., Ltd. · Apr 2025