FDA product code · Anesthesiology

Analyzer, Gas, Nitrogen, Gaseous-Phase

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

CCIClass II21 CFR 868.1690510(k) required2 decisions since 19770 recalls

2 FDA decisions since 1977. 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 CCI 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 · CCI

FDA has decided no CCI device since 2007.

Median 510(k) review, days · CCI

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

Recalls per year · CCI

No recall names CCI since 2007.

Adverse event reports per year · CCI

No MAUDE report names CCI since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
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 — CCI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CCI? 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

Analyzer, Gas, Nitrogen, Gaseous-Phase

What has FDA decided in CCI lately?