510(k) Report

FDA product code · Pathology

Slide Stainer, Immersion Type

KIOClass I21 CFR 864.3800510(k) exempt1 decision since 19890 recalls

FDA lists KIO 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. 1 FDA decision since 1989. 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 KIO 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 · KIO

FDA has decided no KIO device since 2007.

Median 510(k) review, days · KIO

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

Recalls per year · KIO

No recall names KIO since 2007.

Adverse event reports per year · KIO

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

Planning a device in KIO? 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 KIO lately?

  • K890984Linistain SLSShandon, Inc. · 1989

The one KIO decision →

Related product codes

Other codes under 21 CFR 864.3800.

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