510(k) Report

FDA product code · Cardiovascular

Cardiovascular Machine Learning-Based Notification Software

QXOClass II21 CFR 870.2380510(k) required2 decisions since 20230 recalls

2 FDA decisions since 2023. No recall names this code. The most-cited predicate is DEN230003, named by 5 later devices.

Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide…

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 QXO 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 · QXO

1in 2023

2023: 12026 (partial year): 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXO

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

Recalls per year · QXO

No recall names QXO since 2007.

Adverse event reports per year · QXO

No MAUDE report names QXO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20261—0—
FIG. 1 — QXO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QXO? 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

Which predicates do QXO devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN230003Viz HCMViz. Ai, Inc. · 20235cite it

Which QXO devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K260332EchoNextPathwai, Inc. · 20261generation

What has FDA decided in QXO lately?

All 2 QXO decisions →

Related product codes

Other codes under 21 CFR 870.2380.

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