Cleared Traditional

Wearable Breast Pump (Model S9) (K220596) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220596 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
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May 2022
Decision
86d
Days
Class 2
Risk

K220596 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S9). 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 May 26, 2022 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen TPH Technology Co., Ltd. devices

Submission Details

510(k) Number K220596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2022
Decision Date May 26, 2022
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K220596.
Ameda Pearl Electric Breast Pump
K221576 · Ameda, Inc. · Oct 2022
Powered Breast Pump (Models 7V and 7X)
K211016 · Haenim Co., Ltd. · Jun 2022
Wearable Breast Pump (Model S10)
K220309 · Shenzhen Lutejiacheng Technology Co., Ltd. · Jun 2022
Electric Breast Pump
K212564 · Guangdong Horigen Mother & Baby Products Co., Ltd. · May 2022
ARDO Alyssa
K212773 · Ardo Medical AG · Apr 2022
Fit Pro Breast Pump
K212955 · Hygeia II Medical Group, Inc. · Mar 2022