Medela Symphony Breast Pump Model 024
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K020518 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 Symphony Breast Pump Model 024 is a Powered Breast Pump, designed for manual or electric milk expression. It is classified as a Class II medical device and intended for use by lactating individuals to extract breast milk for infant feeding. The device incorporates research-based pumping programs to support milk production and storage, making it suitable for both hospital and home use.
This breast pump is supplied as a reusable, non-sterile device intended for single-user or multi-user settings, such as hospitals or rental programs. It operates on electrical power and includes features for adjusting suction levels and cycle settings. The device has received FDA 510(k) clearance under the Obstetrics/Gynecology advisory committee and is regulated under the 884.5160 product code. No MRI safety information or sterility requirements are specified in the data.
Frequently asked questions
What is the Medela Symphony Breast Pump Model 024 used for?
The Medela Symphony Breast Pump Model 024 is designed for lactating individuals to manually or electrically express breast milk for infant feeding. It is intended for both hospital and home use, supporting milk production and storage through research-based pumping programs.
Is the Medela Symphony Breast Pump Model 024 reusable or single-use?
The Medela Symphony Breast Pump Model 024 is a reusable device, intended for single-user or multi-user settings such as hospitals or rental programs. It is not a single-use product.
What type of power source does the Medela Symphony Breast Pump Model 024 require?
The Medela Symphony Breast Pump Model 024 operates on electrical power. It does not require batteries or manual cranking, making it convenient for continuous use.
Does the Medela Symphony Breast Pump Model 024 come sterile?
The Medela Symphony Breast Pump Model 024 is supplied as a non-sterile device. Sterility is not specified for this model, so it should be cleaned and disinfected according to manufacturer guidelines before use.
What features does the Medela Symphony Breast Pump Model 024 include for customization?
The Medela Symphony Breast Pump Model 024 includes adjustable suction levels and cycle settings, allowing users to customize the pumping experience to their comfort and efficiency. This flexibility supports effective milk expression.
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: Symphony® breast pump | Medela, MEDELA THE SYMPHONY TECHNICAL MANUAL Pdf Download | ManualsLib, Medela Symphony Breast Pump Instruction Manual - Manuals+
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020518 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela, Inc.
Sources (1)
- FDA 510(k) K020518 24 fields · synced Oct 1, 2026