Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

K183646 is the FDA 510(k) clearance record for Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure, a class II device, cleared for Edwards Lifeciences, LLC on 2019-05-21 under FDA product code QAQ (Adjunctive Predictive Cardiovascular Indicator). FDA's definition for product code QAQ reads: "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...". FDA records list 3 510(k) clearances for Edwards Lifeciences, LLC, from 2019-05-01 to 2022-11-07. As of 2026-09-10, FDA records show no recalls naming K183646.