510(k) Report

FDA product code · Cardiovascular

Adjunctive Epicardial Vascular Physiologic Status Indicator

QXZClass II21 CFR 870.2200510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. 510(k) reviews decided 2021–2025 took a median of 123 days (half between 123 and 123). No recall names this code.

The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not…

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 QXZ 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 · QXZ

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXZ

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

Recalls per year · QXZ

No recall names QXZ since 2007.

Adverse event reports per year · QXZ

No MAUDE report names QXZ 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
20260—0—
FIG. 1 — QXZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Which QXZ devices have the deepest lineage?

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

  • K231335Cleerly ISCHEMIACleerly, Inc. · 202314generations

What has FDA decided in QXZ lately?

  • K231335Cleerly ISCHEMIACleerly, Inc. · 2023

The one QXZ decision →

Related product codes

Other codes under 21 CFR 870.2200.

PPW Adjunctive Cardiovascular Status IndicatorQUO Adjunctive Heart Failure Status IndicatorSDJ Adjunctive Cardiac Amyloidosis Status Indicator