FDA product code · Anesthesiology

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

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

BZNClass I21 CFR 868.6175510(k) exempt8 decisions since 19780 recalls

FDA lists BZN 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. 8 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 BZN 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 · BZN

FDA has decided no BZN device since 2007.

Median 510(k) review, days · BZN

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

Recalls per year · BZN

No recall names BZN since 2007.

Adverse event reports per year · BZN

9in 2025

2007high 29 (2022) · low 0 (2011)2025

MAUDE reports naming product code BZN, 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	—	1
2008	—	4
2009	—	4
2010	—	1
2011	—	0
2012	—	2
2013	—	3
2014	—	2
2015	—	6
2016	—	6
2017	—	10
2018	—	3
2019	—	8
2020	—	4
2021	—	8
2022	—	29
2023	—	12
2024	—	7
2025	—	9
2026	—	—

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

Planning a device in BZN? 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

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

What has FDA decided in BZN lately?