FDA product code · Anesthesiology

Calibrator, Pressure, Gas

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

BXXClass I21 CFR 868.2620510(k) exempt10 decisions since 19780 recalls

FDA lists BXX 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. 10 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 BXX 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 · BXX

FDA has decided no BXX device since 2007.

Median 510(k) review, days · BXX

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

Recalls per year · BXX

No recall names BXX since 2007.

Adverse event reports per year · BXX

2in 2012

2007high 2 (2012) · low 0 (2007)2025

MAUDE reports naming product code BXX, 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	—	2
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 — BXX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in BXX? 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

Calibrator, Pressure, Gas

What has FDA decided in BXX lately?