Medela Electric Breast Pump
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K801862 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 Medela Electric Breast Pump is a powered device designed to express breast milk. It functions as a breast pump to assist in the collection of milk for breastfeeding support.
This device is classified as a Class 2 medical device under regulation number 884.5160. It has received FDA 510K clearance for use as an electric breast pump.
Frequently asked questions
What is the primary function of the Medela Electric Breast Pump?
This device is a powered breast pump designed to assist in the expression and collection of breast milk to support breastfeeding.
How is this device classified for regulatory purposes?
The Medela Electric Breast Pump is classified as a Class 2 medical device under regulation number 884.5160, which pertains to powered breast pumps.
Has this device received regulatory authorization?
Yes, the device has received FDA 510K clearance for use as an electric breast pump.
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: Alles Rund ums Stillen und Abpumpen | Medela, Breast Pumps: Advanced Tech for Every Mom | Medela, Breastfeeding & Pumping | Medela, Amazon.com: Medela: Pumps, Medela | Breast Pumps & Nursing Gear | Babylist Shop
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K801862 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela, Inc.
Sources (1)
- FDA 510(k) K801862 24 fields · synced Sep 26, 2026