Cleared Traditional

K222045 - Wearable Breast Pump (Model S1DW)

K222045 is an FDA 510(k) clearance for Wearable Breast Pump (Model S1DW), 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 177-day FDA review.

K222045 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jan 2023
Decision
177d
Days
Class 2
Risk

K222045 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S1DW). 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 January 4, 2023 after a review of 177 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 - K222045

510(k) Number K222045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2022
Decision Date January 04, 2023
Days to Decision 177 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
17d slower than avg
Panel avg: 160d · This submission: 177d
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 K222045.
Electric breast pump (model: M5)
K223693 · Shenzhen Lutejiacheng Technology Co., Ltd. · Mar 2023
imani i2Plus Breast Pump
K222573 · Imani Co. · Mar 2023
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199
K222782 · Zhejiang Carebao Co., Ltd. · Jan 2023
CIMILRE Free-T2 Plus
K221708 · Cimilre Co., Ltd. · Dec 2022
Smartpump 3.0 Double Electric Breast Pump
K222726 · Lansinoh Laboratories · Dec 2022
Spectra Wearable
K220926 · Uzinmedicare Co., Ltd. · Dec 2022