# K964403: Simplicity TM Electric/Battery Breast Pump Kit (1068)

- Pathway: 510(k) (Traditional)
- Applicant: The First Years, Inc.
- Decided: Jan 13, 1997 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Evenflo Sof-Touch Ultra Breast Pump: named in the summary without a submission number

## Indications for use
The powered Simplicity Breast Pump is designed to express milk from the breast.

Source page: https://510kreport.com/device/K964403
Methodology: https://510kreport.com/methodology