Moon Wave Electric Breast Pump (PA220); Mini Moon Electric Breast Pump (PA221)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252583 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
- Models / Variants
- Mini Moon electric breast pump (PA221) FDA 510(k)Moon Wave electric breast pump (PA220) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Moon Wave Electric Breast Pump (PA220) and Mini Moon Electric Breast Pump (PA221) are electrically powered breast pumps designed for personal use. These devices are classified as Pump, Breast, Powered and are intended to mechanically express milk from the breasts of lactating individuals. They operate via motor-driven suction to facilitate milk removal, supporting breastfeeding or milk storage needs.
These devices are supplied as reusable, non-sterile medical instruments intended for home use. They are classified under FDA regulation 884.5160 and received FDA 510(k) clearance under the Substantially Equivalent (SE) designation, with review by the Obstetrics/Gynecology Advisory Committee. No MRI safety or single-use specifications are indicated in the regulatory data. Each model is identified by its unique product code (PA220 or PA221) and falls under product code HGX.
Frequently asked questions
What is the Moon Wave Electric Breast Pump (PA220) used for?
The Moon Wave Electric Breast Pump (PA220) is designed to mechanically express milk from the breasts of lactating individuals. It uses motor-driven suction to facilitate milk removal, making it ideal for supporting breastfeeding or storing expressed milk at home. This device is classified as a powered breast pump and is intended for personal, non-clinical use.
Are the Moon Wave and Mini Moon Electric Breast Pumps (PA220/PA221) single-use or reusable?
Both the Moon Wave Electric Breast Pump (PA220) and Mini Moon Electric Breast Pump (PA221) are supplied as reusable devices. They are intended for home use and are not classified as single-use medical instruments. Reusability is noted in the regulatory data, though users should follow manufacturer guidelines for cleaning and maintenance to ensure safe, repeated use.
What is the sterility status of the Moon Wave Electric Breast Pump (PA220)?
The Moon Wave Electric Breast Pump (PA220) is classified as a non-sterile medical instrument. Since it is intended for home use and reusable, sterility is not required for initial supply. However, proper cleaning and sanitization between uses are critical to prevent contamination and ensure safe operation, as outlined in the manufacturer’s instructions.
How are the Moon Wave and Mini Moon Electric Breast Pumps (PA220/PA221) regulated?
Both the Moon Wave Electric Breast Pump (PA220) and Mini Moon Electric Breast Pump (PA221) are regulated under FDA product code HGX and classification 884.5160. They received FDA 510(k) clearance under the Substantially Equivalent (SE) designation, reviewed by the Obstetrics/Gynecology Advisory Committee. This classification confirms their compliance with U.S. medical device regulations for powered breast pumps.
Can the Moon Wave Electric Breast Pump (PA220) be used in an MRI environment?
The regulatory data for the Moon Wave Electric Breast Pump (PA220) does not specify MRI safety or compatibility. If MRI exposure is a concern, users should consult the manufacturer’s instructions or contact A Cute Baby, Inc. directly for guidance on safe handling near MRI machines. Avoiding MRI use without confirmation could pose risks to both the device and the patient.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mini Moon electric breast pump (PA221); Moon Wave electric breast pump ..., Mini Moon electric breast pump (PA221); Moon Wave electric breast pump ..., K252583 FDA 510(k) - Mini Moon electric breast pump (PA221), Mini Moon electric breast pump (PA221); Moon Wave electric breast pump ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252583 | Class II | Active |
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Manufacturer
- Manufacturer
- A Cute Baby, Inc.
Sources (1)
- FDA 510(k) K252583 24 fields · synced Oct 1, 2026