510(k) Report

FDA product code · Gastroenterology and urology

Rongeur, Cystoscopic, Hot

KDOClass II21 CFR 876.1500510(k) required1 decision since 19930 recalls

1 FDA decision since 1993. 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, gastroenterology and urology panel

Twenty years of KDO 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 · KDO

FDA has decided no KDO device since 2007.

Median 510(k) review, days · KDO

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

Recalls per year · KDO

No recall names KDO since 2007.

Adverse event reports per year · KDO

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

Planning a device in KDO? 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 KDO lately?

  • K914934Hand PackWestmark Hospital Supplies · 1993

The one KDO decision →

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Other codes under 21 CFR 876.1500.

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