Limerick PJ's Comfort Jr Portable Electric Breast Pump
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051926 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, designed to mechanically extract breast milk for feeding infants. It replicates the natural compression and vacuum patterns of infant nursing to stimulate milk production and facilitate efficient milk removal. The pump is classified as a Class II medical device, intended for use in obstetrics and gynecology settings.
The Limerick PJ's Comfort Jr Portable Electric Breast Pump is supplied as a reusable, non-sterile device for home or clinical use. It operates on electrical power and is intended for single-user applications. The device has received FDA 510(k) clearance under the Traditional pathway and is regulated under the classification HGX (Hospital Grade Breast Pump). No MRI safety information or specific sterility requirements are noted in the data.
Frequently asked questions
What is the Limerick PJ’s Comfort Jr Portable Electric Breast Pump used for?
This device is a powered breast pump intended to mechanically extract breast milk for infant feeding. It replicates the natural compression and vacuum patterns of infant nursing to stimulate milk production and facilitate efficient milk removal. It is classified as a Class II medical device and is specifically designed for use in obstetrics and gynecology settings.
Is the Limerick PJ’s Comfort Jr Portable Electric Breast Pump reusable or single-use?
The device is supplied as a reusable breast pump. It is intended for single-user applications, meaning it is meant to be used by one individual only, but it can be reused by that same user over time. There are no specific sterility requirements mentioned, so proper cleaning and maintenance are necessary for reuse.
Does the Limerick PJ’s Comfort Jr Portable Electric Breast Pump require sterilization?
The device is classified as non-sterile and does not require sterilization before use. Since it is reusable and intended for single-user applications, it should be cleaned thoroughly after each use to maintain hygiene. No specific sterility requirements or MRI safety information are noted for this device.
Where can the Limerick PJ’s Comfort Jr Portable Electric Breast Pump be used?
This portable electric breast pump is designed for use in both home and clinical settings. Its portability makes it suitable for use away from a fixed location, such as at home or in a hospital or clinic environment. It is regulated under the classification HGX (Hospital Grade Breast Pump) and is intended for obstetrics and gynecology applications.
What regulatory pathway was followed for the Limerick PJ’s Comfort Jr Portable Electric Breast Pump?
The device received FDA 510(k) clearance under the Traditional pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. The clearance was granted in 2005 and is regulated under the product code HGX, which stands for Hospital Grade 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: PJ's Comfort - Standard - Limerick, PJ's Comfort - Limerick, Limerick PJ's Comfort Standard Electric Breast Pump, Portable ... - Amazon, Limerick PJ's Comfort Electric Breast Pump, Hospital Grade Compression ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051926 | Class II | Active |
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Manufacturer
- Manufacturer
- Limerick, Inc.
Sources (1)
- FDA 510(k) K051926 24 fields · synced Oct 1, 2026