FDA product code · Radiology

System, Tomographic, Nuclear

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

JWMClass II21 CFR 892.1310510(k) required17 decisions since 19781 recall

17 FDA decisions since 1978. 1 recall names this code; it is not Class I. The most-cited predicate is K903315, named by 3 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, radiology panel

Twenty years of JWM 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 · JWM

FDA has decided no JWM device since 2007.

Median 510(k) review, days · JWM

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

Recalls per year · JWM

No recall names JWM since 2007.

Adverse event reports per year · JWM

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

Planning a device in JWM? 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, Tomographic, Nuclear

Which predicates do JWM devices cite most?

What has FDA decided in JWM lately?

What has been recalled in JWM lately?