FDA product code QUO: Adjunctive Heart Failure Status Indicator
QUO is the FDA product code for adjunctive heart failure status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under QUO, 4 in the last five years, from 3 different applicants. The average 510(k) review took 214 days (median 238); 238 days on average over the last three years.
Definition
The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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 Heart Failure Status Indicator |
| Device class | Class II |
| Regulation | 21 CFR 870.2200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QUO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 100 |
| 2023 | 1 | 282 |
| 2024 | 1 | 265 |
| 2025 | 1 | 210 |
Compare with all 510(k) review times · Search every QUO clearance
Top QUO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultromics Limited | 2 | 2024-09-23 |
| Icardio.Ai | 1 | 2025-11-21 |
| Avicena, LLC | 1 | 2023-10-06 |
Most recent QUO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251293 | Icardio.Ai | CardioVision | 2025-11-21 | 210 |
| K240013 | Ultromics Limited | EchoGo Heart Failure (2.0) | 2024-09-23 | 265 |
| K223905 | Avicena, LLC | Vivio® LVEDP System | 2023-10-06 | 282 |
| K222463 | Ultromics Limited | EchoGo Heart Failure | 2022-11-23 | 100 |
Recalls for QUO devices
openFDA lists no recalls for product code QUO.
Frequently asked questions
What is FDA product code QUO?
QUO is the FDA product code for adjunctive heart failure status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel.
What device class is QUO?
Class II, regulation 21 CFR 870.2200. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUO?
Across 4 cleared submissions the average was 214 days from receipt to decision (median 238).
Which companies have the most QUO clearances?
Ultromics Limited (2); Icardio.Ai (1); Avicena, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUO
- Run a recall and safety report across every QUO manufacturer
- Watch product code QUO 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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