FDA product code · Cardiovascular

Medium-Term Adjunctive Predictive Cardiovascular Indicator

Name: FDA decisions, review times, recalls and adverse event reports for product code QNL
Creator: 510(k) Report

QNLClass II21 CFR 870.2210510(k) required6 decisions since 20210 recalls

6 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 211 days (half between 107 and 267). No recall names this code. The most-cited predicate is K200717, named by 4 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, cardiovascular panel

Twenty years of QNL at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QNL

2in 2024

2007high 2 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNL

Too few QNL 510(k)s in any year since 2007 to give a median.

Recalls per year · QNL

No recall names QNL since 2007.

Adverse event reports per year · QNL

No MAUDE report names QNL since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	0
2023	2	—	0
2024	2	—	0
2025	0	—	0
2026	1	—	—

FIG. 1 — QNL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QNL? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 870.2210.

QAQ Adjunctive Predictive Cardiovascular Indicator

Medium-Term Adjunctive Predictive Cardiovascular Indicator

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