# K964396: Double UP Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: The Natural Choice Co., Inc.
- Decided: Jun 6, 1997 after 214 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Double Up Breast Pump is indicated to facilitate expression of milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K964396
Methodology: https://510kreport.com/methodology