# K221708: CIMILRE Free-T2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Cimilre Co., Ltd.
- Decided: Dec 23, 2022 after 193 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.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162870: CIMLRE F1 and CIMILRE S3, Cimilre Co., Ltd. (2017) Summary page 4.

## Indications for use
CIMILRE Free-T2 Plus / CIMILRE Free-T2 is an electrically powered breast pump intended to express and collect breastmilk from lactating women. The device is intended to be used by a single user.

Source page: https://510kreport.com/device/K221708
Methodology: https://510kreport.com/methodology