FDA product code · Anesthesiology

Transducer, Gas Pressure

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

BXOClass I21 CFR 868.2900510(k) exempt2 decisions since 19900 recalls

FDA lists BXO 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. 2 FDA decisions since 1990. 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 BXO 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 · BXO

FDA has decided no BXO device since 2007.

Median 510(k) review, days · BXO

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

Recalls per year · BXO

No recall names BXO since 2007.

Adverse event reports per year · BXO

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

Planning a device in BXO? 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

Transducer, Gas Pressure

What has FDA decided in BXO lately?