FDA product code · Radiology

Collimator, X-Ray

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

EHBClass I21 CFR 872.1840510(k) exempt5 decisions since 19780 recalls

FDA lists EHB as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 5 FDA decisions since 1978. 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 EHB 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 · EHB

FDA has decided no EHB device since 2007.

Median 510(k) review, days · EHB

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

Recalls per year · EHB

No recall names EHB since 2007.

Adverse event reports per year · EHB

1in 2019

2007high 1 (2019) · low 0 (2007)2025

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

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

Planning a device in EHB? 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

Collimator, X-Ray

What has FDA decided in EHB lately?