Medela Clario Home Care Pump
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K033179 FDA 510(k)
- FDA Product Code
- BTA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medela Clario Home Care Pump is a portable, aspiration pump designed for home use. It is a Class II medical device that can be operated manually or powered, providing suction for various medical applications.
The pump is supplied for use in home care settings and is intended for single or multiple uses depending on the application. It is regulated under FDA 510K clearance with product code BTA and is manufactured by Medela LLC. The device operates at atmospheric pressure of 1013.25hPa at sea level, though vacuum levels may vary based on location and environmental conditions.
Frequently asked questions
What is the Medela Clario Home Care Pump used for?
The Medela Clario Home Care Pump is a portable aspiration pump designed for home use, providing suction for various medical applications. It can be operated manually or powered, making it versatile for different home care needs.
Is the Medela Clario Home Care Pump single-use or reusable?
The pump is supplied for single or multiple uses depending on the application. Its reusability depends on the specific medical application and proper maintenance according to manufacturer guidelines.
What are the regulatory approvals for the Medela Clario Home Care Pump?
The device is regulated under FDA 510K clearance with product code BTA. It is classified as a Class II medical device and has been determined to be substantially equivalent to predicate devices in the General and Plastic Surgery specialty areas.
How does the Medela Clario Home Care Pump operate?
The pump operates at atmospheric pressure of 1013.25hPa at sea level and can be used manually or powered. Vacuum levels may vary based on location and environmental conditions, allowing for flexibility in different home care settings.
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: PDF Medela Clario Home Care pump, Alles Rund ums Stillen und Abpumpen | Medela, MEDELA CLARIO INSTRUCTIONS FOR USE MANUAL Pdf Download, Clario Home Care Operating Instructions | Manualzz, Medela Clario Home Care Pump Manual + AI Chat | Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033179 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela AG
Sources (1)
- FDA 510(k) K033179 24 fields · synced Sep 28, 2026