# K202045: imani i1

- Pathway: 510(k) (Traditional)
- Applicant: Imani Co.
- Decided: Feb 26, 2021 after 218 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 4.

## Most influential descendants
- K222573: imani i2Plus Breast Pump (2023), 0 descendants of its own

## Indications for use
The imani i1 is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This device is intended for multiple users.

Source page: https://510kreport.com/device/K202045
Methodology: https://510kreport.com/methodology