FDA product code · Anesthesiology

Forceps, Tube Introduction

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

BWBClass I21 CFR 868.5780510(k) exempt6 decisions since 19820 recalls

FDA lists BWB 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. 6 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, anesthesiology panel

Twenty years of BWB 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 · BWB

FDA has decided no BWB device since 2007.

Median 510(k) review, days · BWB

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

Recalls per year · BWB

No recall names BWB since 2007.

Adverse event reports per year · BWB

1in 2017

2007high 4 (2010) · low 0 (2007)2025

MAUDE reports naming product code BWB, 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	—	4
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in BWB? 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

Forceps, Tube Introduction

What has FDA decided in BWB lately?