Cleared Traditional

K253072 - Paruu Wearable Breast pump (P16

K253072 is an FDA 510(k) clearance for Paruu Wearable Breast pump (P16, manufactured by Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K253072 · Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
91d
Days
Class 2
Risk

K253072 is an FDA 510(k) clearance for the Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P1.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 23, 2025 after a review of 91 days - within the typical 510(k) review window.

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 Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. devices

FDA 510(k) Submission Details - K253072

510(k) Number K253072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2025
Decision Date December 23, 2025
Days to Decision 91 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
69d faster than avg
Panel avg: 160d · This submission: 91d
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 K253072.
Motion InBra (YM-8801) wearable breast pump
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