# K242111: Vivace

- Pathway: 510(k) (Traditional)
- Applicant: Unimom.Co
- Decided: Feb 6, 2025 after 202 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.
1 later device descends from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K260643: Cimilre Dual Max (2026), 0 descendants of its own

## Indications for use
The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The VIVACE is intended for single user and multiple users in home and healthcare environments.

Source page: https://510kreport.com/device/K242111
Methodology: https://510kreport.com/methodology