FDA product code QNL: Medium-Term Adjunctive Predictive Cardiovascular Indicator
QNL is the FDA product code for medium-term 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 6 510(k) submissions under QNL, 5 in the last five years, from 5 different applicants. The average 510(k) review took 208 days (median 235); 223 days on average over the last three years.
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 within a defined medium-term period. 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 | Medium-Term 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 QNL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 297 |
| 2023 | 2 | 158 |
| 2024 | 2 | 187 |
| 2026 | 1 | 259 |
Compare with all 510(k) review times · Search every QNL clearance
Top QNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clew Medical , Ltd. | 2 | 2024-01-13 |
| Epic Systems Corporation | 1 | 2026-09-18 |
| Agilemd, Inc. | 1 | 2024-06-21 |
| Implicity, Inc. | 1 | 2023-10-25 |
| Edwards Lifesciences, LLC | 1 | 2023-07-26 |
Most recent QNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260008 | Epic Systems Corporation | Deterioration Index Version 2 | 2026-09-18 | 259 |
| K233253 | Agilemd, Inc. | eCARTv5 Clinical Deterioration Suite (eCART) | 2024-06-21 | 267 |
| K233216 | Clew Medical , Ltd. | CLEWICU System | 2024-01-13 | 107 |
| K230842 | Implicity, Inc. | SignalHF (IM008) | 2023-10-25 | 211 |
| K231038 | Edwards Lifesciences, LLC | Global Hypoperfusion Index (GHI) Algorithm | 2023-07-26 | 105 |
Recalls for QNL devices
openFDA lists no recalls for product code QNL.
Frequently asked questions
What is FDA product code QNL?
QNL is the FDA product code for medium-term 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 QNL?
Class II, regulation 21 CFR 870.2210. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNL?
Across 6 cleared submissions the average was 208 days from receipt to decision (median 235).
Which companies have the most QNL clearances?
Clew Medical , Ltd. (2); Epic Systems Corporation (1); Agilemd, Inc. (1); Implicity, Inc. (1); Edwards Lifesciences, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QNL
- Run a recall and safety report across every QNL manufacturer
- Watch product code QNL 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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