FDA product code · Immunology

Equipment, Rocket Immunoelectrophoresis

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

JZXClass I21 CFR 866.4830510(k) exempt1 decision since 19940 recalls

FDA lists JZX as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1994. No recall names this code.

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, immunology panel

Twenty years of JZX 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 · JZX

FDA has decided no JZX device since 2007.

Median 510(k) review, days · JZX

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

Recalls per year · JZX

No recall names JZX since 2007.

Adverse event reports per year · JZX

No MAUDE report names JZX since 2007.

View these four charts as a table

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

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

Planning a device in JZX? 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

Equipment, Rocket Immunoelectrophoresis

What has FDA decided in JZX lately?