# K012275: PJ.S Comfort Portable Electric Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Limerick, Inc.
- Decided: Jan 7, 2002 after 172 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: 2 generations back to K850705 (1985). 2 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850705: The White River Porta-Elec-Breast Pump, Natural Technologies, Inc. (1985) Summary page 1.
- K971543: Luxmatic 12-15 Isc Portable Electric Breast Pump, Kaweco GmbH (1997) Summary page 1.

## Most influential descendants
- K051926: Limerick PJ'S Comfort JR Portable Electric Breast Pump (2005), 26 descendants of its own
- K150476: Spectra S1Plus and Spectra S2 Plus (2016), 24 descendants of its own
- K181784: Spectra S3 Plus (2018), 7 descendants of its own
- K180075: MINUET LCD, MINUET LCD eco (2018), 6 descendants of its own
- K190810: OPERA, OPERA eco (2019), 5 descendants of its own

## Indications for use
The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast of lactating women.

Source page: https://510kreport.com/device/K012275
Methodology: https://510kreport.com/methodology