Product Classification

• Device: breast pump accessory, milk expression aid, via positive pressure
• Regulation Description: Nonpowered breast pump.
• Definition: Designed to be used in conjunction with powered or non-powered breast pumps to apply positive pressure to the breast to aid in milk expression from the breasts of a nursing woman.
• Physical State: External device that provides positive pressure to a woman’s breast.
• Technical Method: Provide low, positive pressure to the breast to aid in expression of milk in conjunction with a powered or non-powered breast pump.
• Target Area: Breast
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: PWA
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(K) Exempt
• Regulation Number: 884.5150
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible

Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible