Gerber Double Electric Breast Pump

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

510(k) Number

K043098 ↗

FDA Product Code

HGX

Device Class

Class II

Regulation

21 CFR Part 884.5160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Gerber Precision Care Breast Pump

  Class I

  FDA 510(k) K832597 Active Cleared 12 Sep 1983

• Gerber Precious Care Electric Breast Pump

  Class II

  FDA 510(k) K891996 Active Cleared 7 Aug 1989

• Gerber Natural Comfort Battery Breast Pump

  Class II

  FDA 510(k) K942534 Active Cleared 25 May 1995

• Gerber Precious Care Electric Breast Pump

  Class I

  FDA 510(k) K902552 Active Cleared 26 Sep 1990

• What is the Gerber Double Electric Breast Pump used for?

  The Gerber Double Electric Breast Pump is a powered system designed for expressing milk from lactating women, intended for use with one or both breasts to collect breast milk for feeding infants.

• What components are included with the Gerber Double Electric Breast Pump?

  The device includes a pump base, flexible tubing, funnel assembly, bottles, nipples, nursing pads, and a carrying bag for storage and transport, as specified in the device description.

• Is the Gerber Double Electric Breast Pump a single-use or reusable device?

  The Gerber Double Electric Breast Pump is a reusable system; the pump base, tubing, and funnel assembly are designed for multiple uses, while accessories like bottles and nipples may be reused or replaced based on user needs and hygiene practices.