Cleared Traditional

K254203 - Wearable Breast Pump (Model S36)

K254203 is an FDA 510(k) clearance for Wearable Breast Pump (Model S36), 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 262-day FDA review.

K254203 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
262d
Days
Class 2
Risk

K254203 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S36). 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 September 17, 2026 after a review of 262 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 - K254203

510(k) Number K254203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date September 17, 2026
Days to Decision 262 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
101d slower than avg
Panel avg: 161d · This submission: 262d
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 227
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K254203.
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62)
K261622 · Philips Consumer Lifestyle B.V. · Sep 2026
Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
K262774 · Guangdong Horigen Mother & Baby Products Co., Ltd. · 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