FDA product code · Anesthesiology

Gas, Calibration (Specified Concentration)

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

BXKClass I21 CFR 868.6400510(k) exempt32 decisions since 19820 recalls

FDA lists BXK 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. 32 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 BXK 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 · BXK

FDA has decided no BXK device since 2007.

Median 510(k) review, days · BXK

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

Recalls per year · BXK

No recall names BXK since 2007.

Adverse event reports per year · BXK

2in 2025

2007high 2 (2025) · low 0 (2007)2025

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

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

Planning a device in BXK? 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

Gas, Calibration (Specified Concentration)

What has FDA decided in BXK lately?