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510(k) K183646

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure by Edwards Lifeciences, LLC — Product Code QAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adjunctive Predictive Cardiovascular Indicator
Device Class
Class II
Regulation Number
870.2210
Review Panel
CV
Submission Type

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.

Other clearances by Edwards Lifeciences, LLC

  • K223127 — HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (November 7, 2022)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)

Other clearances for product code QAQ

  • K242518 — Hypertension Prediction Index (HePI) Algorithm (May 15, 2025)
  • K230057 — Acumen Hypotension Prediction Index (HPI) Algorithm (June 8, 2023)
  • K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (July 30, 2021)
  • DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software (March 16, 2018)