510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNLClass II

Medium-Term Adjunctive Predictive Cardiovascular Indicator

21 CFR 870.2210 / Cardiovascular
FDA source (opens on fda.gov)

QNL is the FDA product code for Medium-Term Adjunctive Predictive Cardiovascular Indicator, a class II device type, regulated under 21 CFR 870.2210. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QNL
Device name
Medium-Term Adjunctive Predictive Cardiovascular Indicator
FDA 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.
Regulation
21 CFR 870.2210
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code QNL

By decision year
6 clearances under product code QNL with a decision year between 2021 and 2026, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QNL by decision year
YearClearances
20211
20232
20242
20261

Applicants with the most clearances

Product code QNL
Applicants holding the most 510(k) clearances under product code QNL
ApplicantClearances
Clew Medical, Ltd.2
Agilemd1
Edwards Lifesciences LLC1
Epic Systems Corporation1
Implicity1

Companies listing this code with FDA

Companies whose registered establishments list this code