FDA product code · Radiology

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

JAMClass I21 CFR 892.1330510(k) exempt3 decisions since 19770 recalls

FDA lists JAM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 892.9 applies, such as a new intended use or a different fundamental technology. 3 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, radiology panel

Twenty years of JAM 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 · JAM

FDA has decided no JAM device since 2007.

Median 510(k) review, days · JAM

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

Recalls per year · JAM

No recall names JAM since 2007.

Adverse event reports per year · JAM

1in 2018

2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code JAM, 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	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JAM? 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 JAM lately?