Class Class II
T3 Platform software (K213423)
Description
T3 Platform software by Etiometry, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213423
Clearance Date2023-01-06
Clearance TypeTraditional
Product CodePLB
Regulation Number870.2300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213423
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. T3 Platform software (K213423) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025 |
Trace the full predicate network for K213423
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.