K203224 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform. This device is classified as a Adjunctive Predictive Cardiovascular Indicator (Class II - Special Controls, product code QAQ).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on July 30, 2021, 270 days after receiving the submission on November 2, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2210. 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..
| 510(k) Number | K203224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | July 30, 2021 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QAQ — Adjunctive Predictive Cardiovascular Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2210 |
| 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. |