# QAQ: Adjunctive Predictive Cardiovascular Indicator

- Device class: 2; regulation: 21 CFR 870.2210; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 265 days (middle half 208–268)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2019: 1
- 2021: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- DEN160044: Acumen Hypotension Prediction Index (HPI) Feature Software (2018), cited by 5
- 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 (2019), cited by 3
- K230057: Acumen Hypotension Prediction Index (HPI) Algorithm (2023), cited by 2
- K203224: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform (2021), cited by 1

Source page: https://510kreport.com/product-code/QAQ
Data by year (CSV): https://510kreport.com/product-code/QAQ.csv