# K260643: Cimilre Dual Max

- Pathway: 510(k) (Traditional)
- Applicant: Cimilre Co., Ltd.
- Decided: Aug 21, 2026 after 175 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: 8 generations back to K850705 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242111: Vivace, Unimom.Co (2025) Summary page 5.

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

Source page: https://510kreport.com/device/K260643
Methodology: https://510kreport.com/methodology