FDA product code · Anesthesiology

Monitor, Air Embolism, Ultrasonic

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

CBAClass II21 CFR 868.2025510(k) required1 decision since 19780 recalls

1 FDA decision since 1978. 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 CBA 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 · CBA

FDA has decided no CBA device since 2007.

Median 510(k) review, days · CBA

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

Recalls per year · CBA

No recall names CBA since 2007.

Adverse event reports per year · CBA

No MAUDE report names CBA 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 — CBA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CBA? 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

Monitor, Air Embolism, Ultrasonic

What has FDA decided in CBA lately?