FDA product code QNV: Adjunctive Hemodynamic Indicator With Decision Point
QNV is the FDA product code for adjunctive hemodynamic indicator with decision point. It is a Class II device, regulated under 21 CFR 870.2220 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under QNV, 1 in the last five years. The average 510(k) review took 110 days (median 110). 1 De Novo request was granted under it.
Definition
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Hemodynamic Indicator With Decision Point |
| Device class | Class II |
| Regulation | 21 CFR 870.2220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QNV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 140 |
| 2022 | 1 | 79 |
Compare with all 510(k) review times · Search every QNV clearance
Top QNV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fifth Eye, Inc. | 2 | 2022-07-14 |
Most recent QNV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221203 | Fifth Eye, Inc. | AHI System | 2022-07-14 | 79 |
| K212219 | Fifth Eye, Inc. | AHI System | 2021-12-03 | 140 |
Recalls for QNV devices
openFDA lists no recalls for product code QNV.
Frequently asked questions
What is FDA product code QNV?
QNV is the FDA product code for adjunctive hemodynamic indicator with decision point. It is a Class II device, regulated under 21 CFR 870.2220 and reviewed by the Cardiovascular panel.
What device class is QNV?
Class II, regulation 21 CFR 870.2220. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNV?
Across 2 cleared submissions the average was 110 days from receipt to decision (median 110).
Which companies have the most QNV clearances?
Fifth Eye, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QNV
- Run a recall and safety report across every QNV manufacturer
- Watch product code QNV 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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