FDA product code · Clinical chemistry

System, Test, Breath Nitric Oxide

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

MXAClass II21 CFR 862.3080510(k) required15 decisions since 20030 recalls

15 FDA decisions since 2003. 510(k) reviews decided 2021–2025 took a median of 265 days (half between 180 and 364). No recall names this code. The most-cited predicate is K101034, named by 2 later devices.

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, clinical chemistry panel

Twenty years of MXA 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 · MXA

2in 2025

2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MXA

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

Recalls per year · MXA

No recall names MXA since 2007.

Adverse event reports per year · MXA

No MAUDE report names MXA since 2007.

View these four charts as a table

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

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

Planning a device in MXA? 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

System, Test, Breath Nitric Oxide

Which predicates do MXA devices cite most?

Which MXA devices have the deepest lineage?

What has FDA decided in MXA lately?