Duo Hands-free Breast Pump
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K232608 FDA 510(k)
- FDA Product Code
- HGX 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 Duo Hands-free Breast Pump is a powered breast pump designed for milk collection. It features anatomically shaped collection cups that fit comfortably to each unique breast, allowing for hands-free operation.
This device is supplied as a reusable breast pump with a rechargeable battery. It is intended for use in obstetrics/gynecology settings and is classified as a Class II medical device under regulation number 884.5160.
Frequently asked questions
What is the Duo Hands-free Breast Pump designed for?
The Duo Hands-free Breast Pump is a powered medical device designed for milk collection. It features anatomically shaped collection cups that fit comfortably to each unique breast, allowing for hands-free operation in obstetrics/gynecology settings.
How is the Duo Hands-free Breast Pump supplied and what is its intended use?
This device is supplied as a reusable breast pump with a rechargeable battery. It is intended for use in obstetrics/gynecology settings and is classified as a Class II medical device under regulation number 884.5160.
Is the Duo Hands-free Breast Pump single-use or reusable?
The Duo Hands-free Breast Pump is a reusable device with a rechargeable battery, designed for multiple uses rather than being disposable.
What is the regulatory classification of the Duo Hands-free Breast Pump?
The Duo Hands-free Breast Pump is classified as a Class II medical device under regulation number 884.5160 and has received FDA 510K clearance with the decision code SESE, indicating it is substantially equivalent to other devices on the market.
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: Duo Hands-free™ Double Electric Breast Pump - Medela, Hands-free electric breast pumps - Medela, PDF Duo Hands-Free Breast Pump - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232608 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela, LLC
Sources (1)
- FDA 510(k) K232608 24 fields · synced Oct 1, 2026