# K022140: Whisper Wear Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Whisper Wear
- Decided: Sep 30, 2002 after 90 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: 1 generation back to K901344 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901344: Medela Battery Operated Breast Pump, Medela, Inc. (1990) Summary page 1.

## Indications for use
The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

Source page: https://510kreport.com/device/K022140
Methodology: https://510kreport.com/methodology