# K132220: PJ'S Serenity

- Pathway: 510(k) (Traditional)
- Applicant: Limerick, Inc.
- Decided: Feb 20, 2015 after 583 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K850705 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051926: Limerick PJ'S Comfort JR Portable Electric Breast Pump, Limerick, Inc. (2005) Summary page 4.
- K012275: PJ.S Comfort Portable Electric Breast Pump, Limerick, Inc. (2002) Summary page 4.

## Indications for use
The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother’s milk for future feeding when separation of mother and baby occurs. The device is intended for multiple users.

Source page: https://510kreport.com/device/K132220
Methodology: https://510kreport.com/methodology