Cleared Traditional

K223886 - Wearable Breast Pump (Model S18)

K223886 is an FDA 510(k) clearance for Wearable Breast Pump (Model S18), 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 199-day FDA review.

K223886 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
199d
Days
Class 2
Risk

K223886 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S18). 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 14, 2023 after a review of 199 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 - K223886

510(k) Number K223886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2022
Decision Date July 14, 2023
Days to Decision 199 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 160d · This submission: 199d
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 K223886.
Willow Generation 3 Breast Pump
K230570 · Willow Innovations, Inc. · Oct 2023
Smart double sides wearable breast pump, Electric bilateral breast pump
K230102 · Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · Sep 2023
Annabella Breast Pump
K230672 · Annabella , Ltd. · Aug 2023
Compact Wearable Pump
K230469 · Lansinoh Laboratories · Jun 2023
Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
K230776 · Shenzhen Lutejiacheng Technology Co., Ltd. · Jun 2023
Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
K223329 · Guangzhou Yongyi Industrial Co., Ltd. · May 2023