510(k) Report

FDA product code · Microbiology

Solution, Antimicrobial

LOPClass II21 CFR 866.1640510(k) required3 decisions since 19810 recalls

3 FDA decisions since 1981. 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 LOP 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 · LOP

FDA has decided no LOP device since 2007.

Median 510(k) review, days · LOP

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

Recalls per year · LOP

No recall names LOP since 2007.

Adverse event reports per year · LOP

3in 2009

2009: 3
2007high 3 (2009) · low 0 (2007)2025

MAUDE reports naming product code LOP, 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—00
20080—00
20090—03
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 — LOP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LOP? 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 866.1640.