Cleared Traditional

K142479 - MEGNA BREAST PUMPS

K142479 is an FDA 510(k) clearance for MEGNA BREAST PUMPS, manufactured by Wuxi Xinzhongrui Baby Supplies Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K142479 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
173d
Days
Class 2
Risk

K142479 is an FDA 510(k) clearance for the MEGNA BREAST PUMPS. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Wuxi Xinzhongrui Baby Supplies Co., Ltd. (Wuxi City, CN). The FDA issued a Cleared decision on February 24, 2015 after a review of 173 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 Wuxi Xinzhongrui Baby Supplies Co., Ltd. devices

FDA 510(k) Submission Details - K142479

510(k) Number K142479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2014
Decision Date February 24, 2015
Days to Decision 173 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
12d slower than avg
Panel avg: 161d · This submission: 173d
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 Consultant

Megna, Inc.
DAVID ZENG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 228
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K142479.
Electric Breast Pump
K143585 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · May 2015
Melodi Prime Breast Pump
K143574 · Genadyne Biotechnologies, Inc. · Apr 2015
Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
K150499 · Medela AG · Apr 2015
PJ'S SERENITY
K132220 · Limerick, Inc. · Feb 2015
NATURE'S BOND 600 AND NATURE'S BOND 603
K142168 · Devon Medical Products, Inc. · Dec 2014
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS
K141742 · Ardo Medical AG · Oct 2014