QAQ — Adjunctive Predictive Cardiovascular Indicator Class II
FDA product code QAQ covers "Adjunctive Predictive Cardiovascular Indicator", a Class II medical device regulated under 21 CFR 870.2210. Submissions are reviewed by the Cardiovascular panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QAQ
- Device Class
- Class II
- Regulation Number
- 870.2210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242518 | edwards lifesciences | Hypertension Prediction Index (HePI) Algorithm | May 15, 2025 |
| K230057 | edwards lifesciences | Acumen Hypotension Prediction Index (HPI) Algorithm | June 8, 2023 |
| K203224 | edwards lifesciences | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | July 30, 2021 |
| K183646 | edwards lifeciences | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotensi | May 21, 2019 |
| DEN160044 | edwards lifesciences | Acumen Hypotension Prediction Index (HPI) Feature Software | March 16, 2018 |