FDA product code · Anesthesiology

Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

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

CCEClass II21 CFR 868.1200510(k) required23 decisions since 19760 recalls

23 FDA decisions since 1976. 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 CCE 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 · CCE

FDA has decided no CCE device since 2007.

Median 510(k) review, days · CCE

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

Recalls per year · CCE

No recall names CCE since 2007.

Adverse event reports per year · CCE

2in 2007

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code CCE, 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	—	2
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 — CCE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CCE? 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, Oxygen, Partial Pressure, Blood-Phase, Indwelling

What has FDA decided in CCE lately?