510(k) Report

FDA product code · Anesthesiology

Airway, Esophageal (Obturator)

CAOClass II21 CFR 868.5650510(k) required6 decisions since 19760 recalls

6 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 CAO 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 · CAO

FDA has decided no CAO device since 2007.

Median 510(k) review, days · CAO

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

Recalls per year · CAO

No recall names CAO since 2007.

Adverse event reports per year · CAO

1in 2021

2012: 12013: 12014: 12015: 12017: 12018: 22019: 22020: 12021: 1
2007high 2 (2018) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—01
20130—01
20140—01
20150—01
20160—00
20170—01
20180—02
20190—02
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — CAO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CAO? 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