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MEGNA Breast Pumps

by Wuxi Xinzhongrui Baby Supplies Co., Ltd.

510(k) K142479

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142479 Date24 Feb 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGX
Device Class
Class II
Regulation
21 CFR Part 884.5160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a powered breast pump, as defined by its device name and classification. It is intended for expressing breast milk in a clinical or home setting.

It is supplied as a reusable device, with authorization through FDA 510(k) clearance (K142479). The device is classified as Class II under regulation number 884.5160 and is manufactured by Wuxi Xinzhongrui Baby Supplies Co., Ltd.

Other devices from Wuxi Xinzhongrui Baby Supplies Co., Ltd.