Class Class II
Hypertension Prediction Index (HePI) Algorithm (K242518)
Description
Hypertension Prediction Index (HePI) Algorithm by Edwards Lifesciences, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242518
Clearance Date2025-05-15
Clearance TypeTraditional
Product CodeQAQ
Regulation Number870.2210
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242518
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. Hypertension Prediction Index (HePI) Algorithm (K242518) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, H... | Edwards Lifesciences, LLC | 2022 |
Trace the full predicate network for K242518
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.