Playtex Breast Pump

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

510(k) Number

K022594 ↗

FDA Product Code

HGX

Device Class

Class II

Regulation

21 CFR Part 884.5160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Playtex Deodorant Tampons, Model 34702

  Class II

  FDA 510(k) K020202 Active Cleared 12 Mar 2002

• Playtex Ultimates Silk Glide Tampons #23094

  Class II

  FDA 510(k) K944155 Active Cleared 9 Feb 1995

• Playtex Ultimates Silk Glide Tampons #22994

  Class II

  FDA 510(k) K944154 Active Cleared 9 Feb 1995

• Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons

  Class II

  FDA 510(k) K070745 Active Cleared 13 Apr 2007

• Playtex Deodorant Tampons, Model 34802

  Class II

  FDA 510(k) K020200 Active Cleared 13 Mar 2002

• Playtex Slimfit Tampons

  Class II

  FDA 510(k) K961870 Active Cleared 19 Jun 1996

See all devices from Playtex Products, Inc. →

• What is the Playtex Breast Pump designed for?

  The Playtex Breast Pump is a powered medical device designed specifically for expressing breast milk. It features two independently powered pump units that allow for hands-free pumping, making it convenient for mothers who need to express milk while attending to other tasks.

• How is the Playtex Breast Pump supplied?

  The device is supplied as a complete wearable breast pump system that includes a premium travel case. This makes it portable and convenient for use at home or while traveling, with all necessary components contained in the package.

• What is the regulatory status of the Playtex Breast Pump?

  The Playtex Breast Pump is a Class II medical device that has received FDA 510(k) clearance with the product code HGX. It was determined to be substantially equivalent to other legally marketed devices and is classified under the Obstetrics/Gynecology advisory committee.

• Is the Playtex Breast Pump reusable or single-use?

  The device is designed for multiple uses, though specific components may require replacement over time. The system is intended to be used repeatedly by the same individual, with proper cleaning and maintenance according to the manufacturer's instructions.