FDA product code · Anesthesiology

Flowmeter, Calibration, Gas

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

BXYClass I21 CFR 868.2350510(k) exempt7 decisions since 19780 recalls

FDA lists BXY 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. 7 FDA decisions since 1978. 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 BXY 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 · BXY

FDA has decided no BXY device since 2007.

Median 510(k) review, days · BXY

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

Recalls per year · BXY

No recall names BXY since 2007.

Adverse event reports per year · BXY

1in 2024

2007high 2 (2019) · low 0 (2007)2025

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

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

Planning a device in BXY? 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

Flowmeter, Calibration, Gas

What has FDA decided in BXY lately?