# K232047: Vivace

- Pathway: 510(k) (Traditional)
- Applicant: Unimom.Co
- Decided: Mar 28, 2024 after 262 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: 7 generations back to K850705 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190810: OPERA, OPERA eco, Unimom.Co (2019) Summary page 5.

## Indications for use
The VIVACE is a powered breast pump to be used by lactating women to express and collect milk from their breast. The VIVACE is intended for a single user.

Source page: https://510kreport.com/device/K232047
Methodology: https://510kreport.com/methodology