5 devices · 5 companies · 2021 to 2024
Product code QNL: Medium-Term Adjunctive Predictive Cardiovascular Indicator
5 devices under product code QNL, 2021 to 2024, from 5 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 5 here), the regulation, and MAUDE report counts by product code.
Medium-Term Adjunctive Predictive Cardiovascular Indicator. 21 CFR 870.2210, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| eCARTv5 Clinical Deterioration SuiteK233253 · 510(k) | AgileMD, Inc. | Cardiovascular | database entry | |
| CLEWICU SystemK233216 · 510(k) | Clew Medical Ltd. | Cardiovascular | database entry | |
| SignalHFK230842 · 510(k) | Implicity Inc. | Cardiovascular | database entry | |
| Global Hypoperfusion IndexK231038 · 510(k) | Edwards Lifesciences, LLC | Cardiovascular | database entry | |
| CLEWICU SystemK200717 · 510(k) | CLEW Medical Ltd. | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.