Cleared Traditional

K240536 - Wearable Breast Pump (Model S32)

K240536 is an FDA 510(k) clearance for Wearable Breast Pump (Model S32), 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 126-day FDA review.

K240536 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
126d
Days
Class 2
Risk

K240536 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S32). 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 July 1, 2024 after a review of 126 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 - K240536

510(k) Number K240536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2024
Decision Date July 01, 2024
Days to Decision 126 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
34d faster than avg
Panel avg: 160d · This submission: 126d
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 K240536.
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
K241004 · Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · Sep 2024
BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
K231969 · Dongguanshi Yiyingmei Technology Co., Ltd. · Aug 2024
MilkMate Breast Pump (A0006)
K241705 · Milkmate Products, Inc. · Jul 2024
Annabella Double Breast Pump (ADO-US23-1000)
K241506 · Annabella Tech · Jun 2024
Wearable Breast Pump,Model S18
K232774 · Ningbo Dearevery Electronic Technology Co., Ltd. · Jun 2024
Electric Breast Pump (BRP-301)
K233913 · Aoj Health Technology Co., Ltd. · May 2024