FDA product code · Anesthesiology

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

BXJClass I21 CFR 868.6225510(k) exempt4 decisions since 19760 recalls

FDA lists BXJ 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. 4 FDA decisions since 1976. 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 BXJ 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 · BXJ

FDA has decided no BXJ device since 2007.

Median 510(k) review, days · BXJ

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

Recalls per year · BXJ

No recall names BXJ since 2007.

Adverse event reports per year · BXJ

3in 2025

2007high 4 (2023) · low 0 (2007)2025

MAUDE reports naming product code BXJ, 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	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	2
2022	—	0
2023	—	4
2024	—	0
2025	—	3
2026	—	—

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

Planning a device in BXJ? 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

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What has FDA decided in BXJ lately?