FDA product code · Immunology

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

JZWClass I21 CFR 866.4540510(k) exempt11 decisions since 19760 recalls

FDA lists JZW 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. 11 FDA decisions since 1976. 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 JZW 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 · JZW

FDA has decided no JZW device since 2007.

Median 510(k) review, days · JZW

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

Recalls per year · JZW

No recall names JZW since 2007.

Adverse event reports per year · JZW

2in 2025

2007high 8 (2018) · low 0 (2007)2025

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

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	—	3
2017	—	2
2018	—	8
2019	—	0
2020	—	6
2021	—	6
2022	—	5
2023	—	1
2024	—	2
2025	—	2
2026	—	—

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

Planning a device in JZW? 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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What has FDA decided in JZW lately?