510(k) Report

FDA product code · Ear, nose and throat

Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

LBNClass II21 CFR 874.3495510(k) required1 decision since 19820 recalls

1 FDA decision since 1982. 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 LBN 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 · LBN

FDA has decided no LBN device since 2007.

Median 510(k) review, days · LBN

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

Recalls per year · LBN

No recall names LBN since 2007.

Adverse event reports per year · LBN

No MAUDE report names LBN 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 — LBN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LBN? 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 LBN lately?

  • K822367TOTALTreace Medical, Inc. · 1982

The one LBN decision →

Related product codes

Other codes under 21 CFR 874.3495.

ETA Replacement, Ossicular Prosthesis, Total