FDA product code · Neurology

Chair, Neurosurgical

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

HBNClass I21 CFR 882.4125510(k) exempt4 decisions since 19820 recalls

FDA lists HBN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 4 FDA decisions since 1982. 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, neurology panel

Twenty years of HBN 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 · HBN

FDA has decided no HBN device since 2007.

Median 510(k) review, days · HBN

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

Recalls per year · HBN

No recall names HBN since 2007.

Adverse event reports per year · HBN

2in 2020

2007high 11 (2018) · low 0 (2007)2025

MAUDE reports naming product code HBN, 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	—	4
2016	—	0
2017	—	9
2018	—	11
2019	—	4
2020	—	2
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HBN? 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

Chair, Neurosurgical

What has FDA decided in HBN lately?