# K202037: imani i2

- Pathway: 510(k) (Traditional)
- Applicant: Imani Co.
- Decided: Mar 1, 2021 after 221 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 K801862 (1980). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181863: Elvie Pump, Chiaro Technology Limited (2018) Summary page 4.

## Most influential descendants
- K220926: Spectra Wearable (2022), 1 descendant of its own
- K250208: SPECTRA Wearable 2 (2026), 0 descendants of its own

## Indications for use
The imani i2 breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The imani i2 breast pump is a single user device.

Source page: https://510kreport.com/device/K202037
Methodology: https://510kreport.com/methodology