510(k) Report

FDA product code · Ear, nose and throat

Tube, Tympanostomy, Porous Polyethylene

LBLClass II21 CFR 874.3880510(k) required1 decision since 19900 recalls

1 FDA decision since 1990. 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 LBL 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 · LBL

FDA has decided no LBL device since 2007.

Median 510(k) review, days · LBL

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

Recalls per year · LBL

No recall names LBL since 2007.

Adverse event reports per year · LBL

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

Planning a device in LBL? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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What has FDA decided in LBL lately?

  • K900218J&S HDL Cholesterol Precipitating ReagentJ.S. Medical Assoc. · 1990

The one LBL decision →

Related product codes

Other codes under 21 CFR 874.3880.

OGS Myringotomy Procedure KitETD Tube, Tympanostomy