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E-Basic Single Breast Pump

by MAPA GmbH 510(k)

Active United States

510(k) K101157

Overview

A powered breast pump designed to express milk from the breast by a single user. It utilizes an electrical diaphragm pump to generate an adjustable suck-and-release vacuum pattern with a maximum of 250mmHg. The system is closed, featuring a breast shield connected to a bottle via a valve.

It is supplied as a single-user device and is intended for use in home or clinical settings. The device is classified as a Class II medical device under FDA regulation number 884.5160 and was cleared via the 510(k) pathway (K101157) on September 17, 2010. It is marketed by Mapa GmbH and is not described as sterile, reusable, or MRI-safe in the provided data.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101157 Date17 Sep 2010ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from MAPA GmbH

Questions

  • What is the E-BASIC SINGLE BREAST PUMP used for?

    It is designed to express milk from the breast by a single user, utilizing an electrical diaphragm pump to generate an adjustable suck-and-release vacuum pattern for milk expression in home or clinical settings.

  • How is the E-BASIC SINGLE BREAST PUMP supplied and is it reusable?

    It is supplied as a single-user device, meaning it is intended for use by one individual and is not described as reusable or sterile in the provided data.

  • What is the maximum vacuum pressure of the E-BASIC SINGLE BREAST PUMP?

    The device generates an adjustable suck-and-release vacuum pattern with a maximum of 250mmHg, allowing for customizable milk expression levels.

  • What type of system does the E-BASIC SINGLE BREAST PUMP use?

    It features a closed system where the breast shield is connected to a bottle via a valve, helping to prevent backflow and maintain hygiene during use.