510(k) Report

FDA product code · Ear, nose and throat

Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material

LBPClass II21 CFR 874.3450510(k) required0 decisions0 recalls

0 FDA decisions. 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 LBP 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 · LBP

FDA has decided no LBP device since 2007.

Median 510(k) review, days · LBP

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

Recalls per year · LBP

No recall names LBP since 2007.

Adverse event reports per year · LBP

3in 2025

2007: 12013: 22020: 12022: 12024: 32025: 3
2007high 3 (2024) · low 0 (2008)2025

MAUDE reports naming product code LBP, 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—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—02
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—01
20230—00
20240—03
20250—03
20260—0—
FIG. 1 — LBP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LBP? 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 874.3450.

ETB Prosthesis, Partial Ossicular ReplacementLBM Porous Polyethylene Ossicular Replacement