FDA product code QAQ: Adjunctive Predictive Cardiovascular Indicator
QAQ is the FDA product code for adjunctive predictive cardiovascular indicator. It is a Class II device, regulated under 21 CFR 870.2210 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under QAQ, 2 in the last five years, from 2 different applicants. The average 510(k) review took 208 days (median 208); 265 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Predictive Cardiovascular Indicator |
| Device class | Class II |
| Regulation | 21 CFR 870.2210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QAQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 146 |
| 2021 | 1 | 270 |
| 2023 | 1 | 150 |
| 2025 | 1 | 265 |
Compare with all 510(k) review times · Search every QAQ clearance
Top QAQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edwards Lifesciences, LLC | 3 | 2025-05-15 |
| Edwards Lifeciences, LLC | 1 | 2019-05-21 |
Most recent QAQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242518 | Edwards Lifesciences, LLC | Hypertension Prediction Index (HePI) Algorithm | 2025-05-15 | 265 |
| K230057 | Edwards Lifesciences, LLC | Acumen Hypotension Prediction Index (HPI) Algorithm | 2023-06-08 | 150 |
| K203224 | Edwards Lifesciences, LLC | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | 2021-07-30 | 270 |
| K183646 | Edwards Lifeciences, LLC | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure | 2019-05-21 | 146 |
Recalls for QAQ devices
openFDA lists no recalls for product code QAQ.
Frequently asked questions
What is FDA product code QAQ?
QAQ is the FDA product code for adjunctive predictive cardiovascular indicator. It is a Class II device, regulated under 21 CFR 870.2210 and reviewed by the Cardiovascular panel.
What device class is QAQ?
Class II, regulation 21 CFR 870.2210. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAQ?
Across 4 cleared submissions the average was 208 days from receipt to decision (median 208).
Which companies have the most QAQ clearances?
Edwards Lifesciences, LLC (3); Edwards Lifeciences, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QAQ
- Run a recall and safety report across every QAQ manufacturer
- Watch product code QAQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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