FDA 510(k) · Edwards Lifesciences
K203224: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (Edwards Lifesciences, LLC)
Edwards Lifesciences, LLC received FDA 510(k) K203224 for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform, with a decision date of Jul 30, 2021 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: Form 3881 Type of Use (parsed))
FDA facts
| FDA number | K203224 |
|---|---|
| Pathway | 510(k) |
| Applicant | Edwards Lifesciences, LLC |
| Device name | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform |
| Product code | QAQ: Adjunctive Predictive Cardiovascular Indicator |
| Regulation (21 CFR) | 870.2210 |
| Device class | Class 2 |
| Date received | Nov 2, 2020 |
| Decision date | Jul 30, 2021 |
| 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
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non- surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient’s physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
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 Other, sensor Unknown. These are heuristics, not FDA fields.