FDA product code · Anesthesiology

Attachment, Intermittent Mandatory Ventilation (Imv)

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

CBOClass II21 CFR 868.5955510(k) required15 decisions since 19760 recalls

15 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 CBO 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 · CBO

FDA has decided no CBO device since 2007.

Median 510(k) review, days · CBO

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

Recalls per year · CBO

No recall names CBO since 2007.

Adverse event reports per year · CBO

1in 2015

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code CBO, 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	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in CBO? 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

Attachment, Intermittent Mandatory Ventilation (Imv)

What has FDA decided in CBO lately?