FDA product code · Anesthesiology

Protector, Dental

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

BRWClass I21 CFR 868.5820510(k) exempt3 decisions since 19850 recalls

FDA lists BRW as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 868.9 applies, such as a new intended use or a different fundamental technology. 3 FDA decisions since 1985. 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, anesthesiology panel

Twenty years of BRW 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 · BRW

FDA has decided no BRW device since 2007.

Median 510(k) review, days · BRW

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

Recalls per year · BRW

No recall names BRW since 2007.

Adverse event reports per year · BRW

1in 2025

2007high 3 (2011) · low 0 (2008)2025

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

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

Planning a device in BRW? 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

Protector, Dental

What has FDA decided in BRW lately?