FDA product code · Neurology

Rack, Clip

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

HBRClass I21 CFR 882.4215510(k) exempt1 decision since 19890 recalls

FDA lists HBR 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. 1 FDA decision since 1989. 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 HBR 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 · HBR

FDA has decided no HBR device since 2007.

Median 510(k) review, days · HBR

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

Recalls per year · HBR

No recall names HBR since 2007.

Adverse event reports per year · HBR

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

Planning a device in HBR? 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

Rack, Clip

What has FDA decided in HBR lately?