# K222573: imani i2Plus Breast Pump

- Pathway: 510(k) (Traditional)
- Applicant: Imani Co.
- Decided: Mar 3, 2023 after 190 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)
- K202045: imani i1, Imani Co. (2021) Summary page 4.

## Indications for use
The imani i2Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The imani i2Plus Breast Pump is a single user device.

Source page: https://510kreport.com/device/K222573
Methodology: https://510kreport.com/methodology