510(k) Report

FDA product code · Anesthesiology

Applicator (Laryngo-Tracheal), Topical Anesthesia

CCTClass II21 CFR 868.5170510(k) required10 decisions since 19764 recalls

10 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 274 days (half between 274 and 274). 4 recalls name this code, 0 of them Class I. The most-cited predicate is K002255, named by 4 later devices.

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 CCT 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 · CCT

1in 2024

2007: 12011: 12016: 12018: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCT

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

Recalls per year · CCT

1in 2016

2009: 32016: 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CCT

2in 2025

2010: 32012: 12014: 12015: 42017: 22021: 32022: 32023: 22024: 22025: 2
2007high 4 (2015) · low 0 (2007)2025

MAUDE reports naming product code CCT, 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
20071—00
20080—00
20090—30
20100—03
20111—00
20120—01
20130—00
20140—01
20150—04
20161—10
20170—02
20181—00
20190—00
20200—00
20210—03
20220—03
20230—02
20241—02
20250—02
20260—0—
FIG. 1 — CCT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CCT? 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