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Nuk Expressivetm Double Electric Breast Pump

by MAPA GmbH 510(k)

Active United States

510(k) K121478

Overview

The Nuk Expressive Double Electric Breast Pump is a Powered Breast Pump designed to mechanically express milk from both breasts simultaneously. It employs an adjustable vacuum system with a suck-and-release pattern to simulate natural nursing, facilitating efficient milk removal for lactating individuals.

This device is supplied as a reusable system comprising an electric pumping unit, silicone tubing, breast shields, and breast milk containers. It is intended for single-user home or clinical use and requires no special regulatory conditions beyond standard electrical safety standards. The device operates with adjustable suction strength and cycle rates (30–90 cycles per minute) and is classified under FDA product code HGX as a Class II medical device with Special Controls.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121478 Date5 Apr 2013ClearedStatusActive

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 NUK Expressive Double Electric Breast Pump designed for?

    This device is specifically designed to mechanically express milk from both breasts simultaneously, simulating natural nursing through an adjustable vacuum system with a suck-and-release pattern. It is intended for lactating individuals who need to efficiently remove milk for feeding or storage, whether in home or clinical environments.

  • How is the NUK Expressive Double Electric Breast Pump supplied, and is it reusable?

    The pump is supplied as a reusable system, including an electric pumping unit, silicone tubing, breast shields, and breast milk containers. All components are intended for single-user use only, ensuring hygiene and safety for the individual expressing milk.

  • Does the NUK Expressive Double Electric Breast Pump require special handling or storage?

    The device does not have specialized regulatory storage conditions beyond standard electrical safety requirements. However, reusable components should be cleaned and sanitized according to manufacturer guidelines after each use to maintain hygiene. Store the pump in a clean, dry place when not in use.

  • Can the suction strength and cycle rates be adjusted, and what are the available ranges?

    Yes, the NUK Expressive Double Electric Breast Pump features adjustable suction strength and cycle rates. The cycle rates can be set between 30 and 90 cycles per minute, allowing users to customize the pumping experience to their comfort and efficiency needs.

  • Is the NUK Expressive Double Electric Breast Pump approved for clinical or home use?

    The device is approved for both home and clinical use, as it is classified as a Class II medical device under FDA product code HGX. It meets standard electrical safety requirements and is intended for single-user operation, making it suitable for diverse settings.