Cleared Traditional

K252420 - Wearable Breast Pump (Model W12)

K252420 is an FDA 510(k) clearance for Wearable Breast Pump (Model W12), 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 196-day FDA review.

K252420 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 2026
Decision
196d
Days
Class 2
Risk

K252420 is an FDA 510(k) clearance for the Wearable Breast Pump (Model W12). 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 February 13, 2026 after a review of 196 days - an extended review 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: 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 - K252420

510(k) Number K252420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2025
Decision Date February 13, 2026
Days to Decision 196 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
36d slower than avg
Panel avg: 160d · This submission: 196d
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 K252420.
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
K252744 · Cixi Ruihong Electric Appliance Co., Ltd. · Apr 2026
Mini Moon electric breast pump (PA221)
K252583 · A Cute Baby, Inc. · Mar 2026
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
K253934 · Shenzhen Root Innovation Technology Co., Ltd. · Mar 2026
Wearable Breast Pump (Model W2)
K252422 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Motion InBra (YM-8801) wearable breast pump
K253149 · Medela, LLC · Feb 2026
Spectra S1 Pro
K251423 · Uzinmedicare Co., Ltd. · Feb 2026