510(k) Report

FDA product code · Anesthesiology

Analyzer, Gas, Oxygen, Gaseous-Phase

CCLClass II21 CFR 868.1720510(k) required122 decisions since 19762 recalls

122 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 112 days (half between 111 and 246). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K051092, named by 8 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 CCL 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 · CCL

2in 2025

2007: 22008: 22011: 12013: 22016: 12018: 12022: 22023: 12025: 22026 (partial year): 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCL

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

Recalls per year · CCL

1in 2009

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

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

Adverse event reports per year · CCL

2in 2025

2007: 12008: 22009: 22010: 52011: 42012: 52013: 32014: 82015: 52016: 12017: 22018: 12019: 12020: 12021: 32023: 42024: 42025: 2
2007high 8 (2014) · low 0 (2022)2025

MAUDE reports naming product code CCL, 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
20072—01
20082—02
20090—12
20100—05
20111—04
20120—05
20132—03
20140—08
20150—05
20161—01
20170—02
20181—01
20190—01
20200—01
20210—03
20222—00
20231—04
20240—04
20252—02
20261—0—
FIG. 1 — CCL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CCL? 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