Class Class II
Etiometry Platform (DAV 5.4 RAE 9.2) (K241479)
Description
Etiometry Platform (DAV 5.4 RAE 9.2) by Etiometry, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241479
Clearance Date2025-02-12
Clearance TypeTraditional
Product CodePPW
Regulation Number870.2200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241479
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. Etiometry Platform (DAV 5.4 RAE 9.2) (K241479) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223578 | T3 Platform software | Etiometry, Inc. | 2023 |
| K213423 | T3 Platform software | Etiometry, Inc. | 2023 |
Trace the full predicate network for K241479
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.