Cleared Traditional

Lacevo Wearable Breast Pump (Model S70) (K250829) - FDA 510(k) Clearance

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

K250829 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 2025
Decision
29d
Days
Class 2
Risk

K250829 is an FDA 510(k) clearance for the Lacevo Wearable Breast Pump (Model S70). 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 April 17, 2025 after a review of 29 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 K250829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2025
Decision Date April 17, 2025
Days to Decision 29 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
131d faster than avg
Panel avg: 160d · This submission: 29d
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 K250829.
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