Lansinoh Powered Electric Breast Pump
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122474 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 Lansinoh Powered Electric Breast Pump is a powered breast pump designed to express and collect breast milk from nursing women for feeding to babies. It operates using a diaphragm-type vacuum pump driven by a microprocessor and can be powered by 6 AA batteries or an AC adaptor provided with the pump.
This device is supplied as a single-use or reusable product, though specific sterility information is not provided in the data. It is FDA 510(k) cleared with product code HGX and is classified as a Class II medical device in the Obstetrics/Gynecology specialty. The device is available in various models as indicated by the multiple registration numbers in the FDA database.
Frequently asked questions
What is the Lansinoh Powered Electric Breast Pump used for?
The Lansinoh Powered Electric Breast Pump is designed to express and collect breast milk from nursing women for feeding to babies. It uses a diaphragm-type vacuum pump driven by a microprocessor to efficiently extract milk.
How is the Lansinoh Powered Electric Breast Pump powered?
The pump can be powered by either 6 AA batteries or an AC adaptor that is provided with the pump, offering flexibility for use at home or on the go.
Is the Lansinoh Powered Electric Breast Pump single-use or reusable?
The device is supplied as either a single-use or reusable product, though specific sterility information is not provided in the available data.
What is the regulatory classification of this breast pump?
The Lansinoh Powered Electric Breast Pump is FDA 510(k) cleared with product code HGX and is classified as a Class II medical device in the Obstetrics/Gynecology specialty.
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: K182749 - Pump, Breast, Powered FDA 510 (k) APPLICATION FOR Lansinoh ..., fda.innolitics.com, PDF Pro™ - Food and Drug Administration, DEVICE: Lansinoh Smart Pump - DME (00044677531160), K182749 - Pump, Breast, Powered FDA 510 (k) APPLICATION FOR Lansinoh ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122474 | Class II | Active |
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Manufacturer
- Manufacturer
- Lansinoh Laboratories Saglik Gerecleri Tasarim San
Sources (1)
- FDA 510(k) K122474 24 fields · synced Oct 6, 2026