Cleared Traditional

K212180 - Wearable Breast Pump (Model S12)

K212180 is an FDA 510(k) clearance for Wearable Breast Pump (Model S12), 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 214-day FDA review.

K212180 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
214d
Days
Class 2
Risk

K212180 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S12). 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 11, 2022 after a review of 214 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 - K212180

510(k) Number K212180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date February 11, 2022
Days to Decision 214 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
54d slower than avg
Panel avg: 160d · This submission: 214d
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 K212180.
ARDO Alyssa
K212773 · Ardo Medical AG · Apr 2022
Fit Pro Breast Pump
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K211024 · Shantou Huihengqi Electronic Technology Co., Ltd. · Feb 2022
Lucy Breast Pump
K213311 · Willow Innovations, Inc. · Feb 2022
Electric breast pump
K212884 · Dongguan Rongfeng Medical Co., Ltd. · Jan 2022
Electric Breast Pump
K211755 · Zhejiang Carebao Co., Ltd. · Dec 2021