510(k) Report

FDA product code · Anesthesiology

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

CCJClass II21 CFR 868.1430510(k) required28 decisions since 19760 recalls

28 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 303 days (half between 243 and 362). No recall names this code. The most-cited predicate is K171408, 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 CCJ 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 · CCJ

2in 2021

2008: 22010: 12012: 12014: 12015: 12017: 12018: 12019: 12021: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCJ

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

Recalls per year · CCJ

No recall names CCJ since 2007.

Adverse event reports per year · CCJ

No MAUDE report names CCJ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—00
20101—00
20110—00
20121—00
20130—00
20141—00
20151—00
20160—00
20171—00
20181—00
20191—00
20200—00
20212—00
20220—00
20230—00
20240—00
20250—00
20261—0—
FIG. 1 — CCJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CCJ? 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