FDA product code · Physical medicine

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

ILZClass I21 CFR 890.5925510(k) exempt15 decisions since 19770 recalls

FDA lists ILZ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 15 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, physical medicine panel

Twenty years of ILZ 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 · ILZ

FDA has decided no ILZ device since 2007.

Median 510(k) review, days · ILZ

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

Recalls per year · ILZ

No recall names ILZ since 2007.

Adverse event reports per year · ILZ

1in 2023

2007high 11 (2008) · low 0 (2014)2025

MAUDE reports naming product code ILZ, 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	—	4
2008	—	11
2009	—	5
2010	—	4
2011	—	1
2012	—	2
2013	—	3
2014	—	0
2015	—	1
2016	—	2
2017	—	1
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	1
2023	—	1
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in ILZ? 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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Other codes under 21 CFR 890.5925.

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What has FDA decided in ILZ lately?

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