510(k) Report

FDA product code · Microbiology

Discs, Elution

LTXClass II21 CFR 866.1620510(k) required2 decisions since 19800 recalls

2 FDA decisions since 1980. 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, microbiology panel

Twenty years of LTX 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 · LTX

FDA has decided no LTX device since 2007.

Median 510(k) review, days · LTX

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

Recalls per year · LTX

No recall names LTX since 2007.

Adverse event reports per year · LTX

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

Planning a device in LTX? 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 LTX lately?

  • K002139Etest LinezolidAb Biodisk · 2000
  • K992993Etest for Quinupristin/DalfopristinAb Biodisk · 1999

All 2 LTX decisions →

Related product codes

Other codes under 21 CFR 866.1620.

JTN Susceptibility Test Discs, Antimicrobial