510(k) Report

FDA product code · Ear, nose and throat

Bougie, Eustachian

KBIClass I21 CFR 874.4175510(k) exempt1 decision since 19770 recalls

FDA lists KBI as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1977. No recall names this code.

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, ear, nose and throat panel

Twenty years of KBI 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 · KBI

FDA has decided no KBI device since 2007.

Median 510(k) review, days · KBI

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

Recalls per year · KBI

No recall names KBI since 2007.

Adverse event reports per year · KBI

No MAUDE report names KBI since 2007.

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—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — KBI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KBI? 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

What has FDA decided in KBI lately?

  • K770959Bougie, Filiform, JacksonV. Mueller O.V. Baxter Healthcare Corp. · 1977

The one KBI decision →

Related product codes

Other codes under 21 CFR 874.4175.

ENW Catheter, NasopharyngealKBY Set, Filliform, Eustachian