FDA product code · Anesthesiology

Plethysmograph, Pressure

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

CCMClass II21 CFR 868.1750510(k) required11 decisions since 19780 recalls

11 FDA decisions since 1978. No recall names this code. The most-cited predicate is K853390, named by 1 later device.

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 CCM 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 · CCM

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCM

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

Recalls per year · CCM

No recall names CCM since 2007.

Adverse event reports per year · CCM

1in 2023

2007high 3 (2020) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	1
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	3
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

FIG. 1 — CCM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CCM? 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

Plethysmograph, Pressure

Which predicates do CCM devices cite most?

Which CCM devices have the deepest lineage?

What has FDA decided in CCM lately?