FDA 510(k) · Edwards Lifesciences
K242518: Hypertension Prediction Index (HePI) Algorithm (Edwards Lifesciences, LLC)
Edwards Lifesciences, LLC received FDA 510(k) K242518 for Hypertension Prediction Index (HePI) Algorithm, with a decision date of May 15, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K242518 |
|---|---|
| Pathway | 510(k) |
| Applicant | Edwards Lifesciences, LLC |
| Device name | Hypertension Prediction Index (HePI) Algorithm |
| Product code | QAQ: Adjunctive Predictive Cardiovascular Indicator |
| Regulation (21 CFR) | 870.2210 |
| Device class | Class 2 |
| Date received | Aug 23, 2024 |
| Decision date | May 15, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QAQ is "Adjunctive Predictive Cardiovascular Indicator", class 2, 21 CFR 870.2210. FDA's definition: "The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy."
Our labels for filtering: claim Blood pressure, sensor Unknown. These are heuristics, not FDA fields.