510(k) Report

FDA product code · Pathology

Microscope, Inverted Stage, Tissue Culture

IBLClass I21 CFR 864.3600510(k) exempt0 decisions0 recalls

FDA lists IBL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 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, pathology panel

Twenty years of IBL 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 · IBL

FDA has decided no IBL device since 2007.

Median 510(k) review, days · IBL

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

Recalls per year · IBL

No recall names IBL since 2007.

Adverse event reports per year · IBL

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

Planning a device in IBL? 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 864.3600.

KEH Micrometers, MicroscopeKEG Lamps, MicroscopeIBM Microscope, Phase ContrastKEJ Stages, MicroscopeKEI Condensers, MicroscopeIBJ Light, MicroscopeIBK Microscope, Fluorescence/U.V.