510(k) Report

FDA product code · Anesthesiology

Vaporizer, Anesthesia, Non-Heated

CADClass II21 CFR 868.5880510(k) required57 decisions since 197610 recalls

57 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 267 days (half between 267 and 267). 10 recalls name this code, 2 of them Class I. The most-cited predicate is K942091, named by 5 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 CAD 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 · CAD

1in 2024

2011: 12015: 12018: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAD

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

Recalls per year · CAD

2in 2025

2024: 52025: 2, 2 Class I
2007high 5 (2024) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CAD

2,678in 2025

2007: 302008: 292009: 392010: 322011: 412012: 142013: 122014: 52015: 412016: 92017: 142018: 112019: 122020: 112021: 122022: 132023: 442024: 2552025: 2,678
2007high 2,678 (2025) · low 5 (2014)2025

MAUDE reports naming product code CAD, 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—030
20080—029
20090—039
20100—032
20111—041
20120—014
20130—012
20140—05
20151—041
20160—09
20170—014
20181—011
20190—012
20200—011
20210—012
20220—013
20230—044
20241—5255
20250—2 (2)2,678
20260—0—
FIG. 1 — CAD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CAD? 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