510(k) Report

FDA product code · Anesthesiology

Orotracheal Intubation Guide Kit

OGKClass II21 CFR 868.14000 decisions0 recalls

0 FDA decisions. No recall names this code.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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 OGK 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 · OGK

FDA has decided no OGK device since 2007.

Median 510(k) review, days · OGK

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

Recalls per year · OGK

No recall names OGK since 2007.

Adverse event reports per year · OGK

2in 2023

2019: 12023: 2
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code OGK, 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
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—02
20240—00
20250—00
20260—0—
FIG. 1 — OGK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OGK? 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

Related product codes

Other codes under 21 CFR 868.1400.

CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase