510(k) Report

FDA product code · Anesthesiology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

CAPClass II21 CFR 868.2600510(k) required78 decisions since 19780 recalls

78 FDA decisions since 1978. No recall names this code. The most-cited predicate is K992101, 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 CAP 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 · CAP

1in 2020

2008: 12010: 12011: 22012: 12013: 22014: 12015: 12016: 12018: 12019: 22020: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAP

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

Recalls per year · CAP

No recall names CAP since 2007.

Adverse event reports per year · CAP

2in 2025

2009: 12012: 32019: 42020: 12021: 52022: 62023: 112024: 112025: 2
2007high 11 (2023) · low 0 (2007)2025

MAUDE reports naming product code CAP, 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
20081—00
20090—01
20101—00
20112—00
20121—03
20132—00
20141—00
20151—00
20161—00
20170—00
20181—00
20192—04
20201—01
20210—05
20220—06
20230—011
20240—011
20250—02
20260—0—
FIG. 1 — CAP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CAP? 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