Product code QAQ— Cardiovascular
Acumen Hypotension Prediction Index (HPI) Algorithm
- Classification name
- Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class 2
- Regulation
- 21 CFR 870.2210
- Advisory panel
- Cardiovascular
- Total cleared
- 5
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QAQ
FDA has cleared devices under product code QAQ between 2018 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
- 2021
- 2019
- 2018
Top applicants under product code QAQ
Recent clearances under product code QAQ
- K242518 — Hypertension Prediction Index (HePI) Algorithm
- K230057 — Acumen Hypotension Prediction Index (HPI) Algorithm
- K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
- 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
- DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software
Data sourced from openFDA. This site is unofficial and independent of the FDA.