510(k) Report

FDA product code · Anesthesiology

Analyzer, Gas, Argon, Gaseous-Phase

JEGClass II21 CFR 868.1075510(k) required1 decision since 19880 recalls

1 FDA decision since 1988. 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 JEG 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 · JEG

FDA has decided no JEG device since 2007.

Median 510(k) review, days · JEG

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

Recalls per year · JEG

No recall names JEG since 2007.

Adverse event reports per year · JEG

No MAUDE report names JEG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — JEG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JEG? 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