Medela Pump In Style Advanced Breast Pump
FDA 510(k)Class II (US FDA 510(k))
by Medela LLC
Identifiers
- 510(k) Number
- K031614 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)
This device is a powered breast pump. It is classified as a Class II medical device under FDA regulation number 884.5160.
The device received FDA 510(k) clearance (K031614) on June 6, 2003, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Medela LLC and is intended for use in expressing breast milk.
Frequently asked questions
What is the Medela Pump In Style Advanced Breast Pump used for?
The Medela Pump In Style Advanced Breast Pump is intended for expressing breast milk. It is a powered device designed to assist lactating individuals in milk extraction, as stated in its FDA 510(k) submission.
How is the Medela Pump In Style Advanced Breast Pump supplied and is it reusable?
The device is supplied as a powered breast pump system. While the data does not specify single-use or reusable components, it is a durable electric pump intended for repeated use with appropriate cleaning of accessible parts, consistent with standard breast pump design.
What regulatory pathway was used for the Medela Pump In Style Advanced Breast Pump?
The Medela Pump In Style Advanced Breast Pump received FDA 510(k) clearance under number K031614 on June 6, 2003, and was determined to be substantially equivalent to a legally marketed predicate device.
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 Pump In Style Advanced - Medela, Alles Rund ums Stillen und Abpumpen | Medela, Breast Pumps: Advanced Tech for Every Mom | Medela, Medela Pump In Style Advanced Breast Pump for Feeding, Medela Pump In Style Advanced Manual | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031614 | Class II | Active |
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Manufacturer
- Manufacturer
- Medela LLC
- FDA Applicant
- Medela, Inc.
Sources (1)
- FDA 510(k) K031614 24 fields · synced Sep 24, 2026