Class Class II
imani i2Plus Breast Pump (K222573)
Description
imani i2Plus Breast Pump by Imani Co., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222573
Clearance Date2023-03-03
Clearance TypeTraditional
Product CodeHGX
Regulation Number884.5160
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222573
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. imani i2Plus Breast Pump (K222573) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202037 | imani i2 | Imani Co. | 2021 |
| K202045 | imani i1 | Imani Co. | 2021 |
Trace the full predicate network for K222573
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.