Class Class II
Prismira (K243729)
Description
Prismira by Lumos Labs, Inc., an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243729
Clearance Date2025-06-13
Clearance TypeTraditional
Product CodeQFT
Regulation Number882.5803
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243729
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. Prismira (K243729) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233496 | EndeavorOTC | Akili Interactive Labs, Inc. | 2024 |
| K231337 | EndeavorRx | Akili Interactive Labs, Inc. | 2023 |
Trace the full predicate network for K243729
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.