Gentle Expressions Automatic Breast Pump & Feed Sy

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

510(k) Number

K852460 ↗

FDA Product Code

HGX

Device Class

Class II

Regulation

21 CFR Part 884.5160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Healthteam Digital Blood Pressure Kit 8115

  Class II

  FDA 510(k) K852653 Active Cleared 30 Dec 1985

• Infrared Hex

  Class II

  FDA 510(k) K890585 Active Cleared 22 Aug 1989

• Healthteam Digital Blood Pressure Kit 8145

  Class II

  FDA 510(k) K852458 Active Cleared 30 Dec 1985

• Healthteam Digital Blood Pressure Kit 8175

  Class II

  FDA 510(k) K852459 Active Cleared 30 Dec 1985

• Healthteam Digital Blood Pressure Kit 8165

  Class II

  FDA 510(k) K852457 Active Cleared 30 Dec 1985

• Gentle Expressions Electric Breast Pump

  Class II

  FDA 510(k) K890588 Active Cleared 16 May 1989

See all devices from Healthteam →

• Is this breast pump designed for single-use or can it be reused after cleaning and sterilization?

  The Gentle Expressions Automatic Breast Pump & Feed System is supplied as a reusable device. Components require cleaning and sterilization between uses to maintain hygiene and functionality, as explicitly stated in the device description.

• What types of settings or specialties is this breast pump intended to support in a clinical or home environment?

  The device is classified under the medical specialty of Obstetrics/Gynecology and was reviewed by the Obstetrics/Gynecology Advisory Committee, indicating its primary focus is on lactation support for mothers, whether for medical necessity or convenience.

• Are there multiple models or sizes available for this breast pump, or is it a one-size-fits-all design?

  The provided data does not specify any size variations or distinct models for the Gentle Expressions Automatic Breast Pump & Feed System, so it appears to be a single design intended for general home use.

• How is this breast pump authorized for use in the United States?

  The Gentle Expressions Automatic Breast Pump & Feed System holds FDA 510(k) clearance under the registration number K852460, indicating it has been deemed substantially equivalent to a legally marketed predicate device through the traditional clearance process.

• Does this device require any special storage conditions, and is it intended for home use only?

  The device is explicitly designed for home use, but specific storage conditions are not detailed in the provided data. Standard care for reusable medical devices, such as keeping it clean and dry when not in use, would likely be recommended.