# K190810: OPERA, OPERA eco

- Pathway: 510(k) (Traditional)
- Applicant: Unimom.Co
- Decided: Aug 30, 2019 after 154 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: 6 generations back to K850705 (1985). 9 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180075: MINUET LCD, MINUET LCD eco, Unimom.Co (2018) Summary page 4.

## Most influential descendants
- K242111: Vivace (2025), 1 descendant of its own
- K202045: imani i1 (2021), 1 descendant of its own
- K260643: Cimilre Dual Max (2026), 0 descendants of its own
- K232047: Vivace (2024), 0 descendants of its own
- K222573: imani i2Plus Breast Pump (2023), 0 descendants of its own

## Indications for use
The OPERA and OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

Source page: https://510kreport.com/device/K190810
Methodology: https://510kreport.com/methodology