510(k) Report

FDA product code · Anesthesiology

Computer, Oxygen-Uptake

BZLClass II21 CFR 868.1730510(k) required33 decisions since 19800 recalls

33 FDA decisions since 1980. No recall names this code. The most-cited predicate is K021490, named by 2 later devices.

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 BZL 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 · BZL

2in 2020

2007: 22010: 12011: 12020: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZL

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

Recalls per year · BZL

No recall names BZL since 2007.

Adverse event reports per year · BZL

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code BZL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20080—00
20090—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20202—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — BZL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in BZL? 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