510(k) Report

FDA product code · Anesthesiology

Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

CBRClass II21 CFR 868.1700510(k) required5 decisions since 19852 recalls

5 FDA decisions since 1985. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K954962, named by 2 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 CBR 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 · CBR

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBR

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

Recalls per year · CBR

1in 2011

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

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

Adverse event reports per year · CBR

1in 2025

2008: 12009: 12010: 12011: 12012: 82013: 12015: 12020: 12025: 1
2007high 8 (2012) · low 0 (2007)2025

MAUDE reports naming product code CBR, 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—10
20080—01
20090—01
20100—01
20111—11
20120—08
20130—01
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — CBR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CBR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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