FDA product code · Immunology

Electrophoresis Instrumentation

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

JZSClass I21 CFR 866.4500510(k) exempt6 decisions since 19770 recalls

FDA lists JZS 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. 6 FDA decisions since 1977. 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 JZS 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 · JZS

FDA has decided no JZS device since 2007.

Median 510(k) review, days · JZS

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

Recalls per year · JZS

No recall names JZS since 2007.

Adverse event reports per year · JZS

No MAUDE report names JZS 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 — JZS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JZS? 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

Electrophoresis Instrumentation

What has FDA decided in JZS lately?