FDA product code · Neurology

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

JXLClass II21 CFR 882.5070510(k) required28 decisions since 19760 recalls

28 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 332 days (half between 305 and 358). No recall names this code. The most-cited predicate is K992269, named by 4 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, neurology panel

Twenty years of JXL 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 · JXL

1in 2023

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXL

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

Recalls per year · JXL

No recall names JXL since 2007.

Adverse event reports per year · JXL

3in 2022

2007high 14 (2010) · low 0 (2016)2025

MAUDE reports naming product code JXL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	1
2008	0	—	12
2009	0	—	3
2010	0	—	14
2011	0	—	5
2012	0	—	4
2013	0	—	3
2014	0	—	3
2015	1	—	5
2016	0	—	0
2017	1	—	1
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	3
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in JXL? 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

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Which predicates do JXL devices cite most?

Which JXL devices have the deepest lineage?

What has FDA decided in JXL lately?