510(k) Report

FDA product code · Gastroenterology and urology

Accessories, A-V Shunt

KNZClass II21 CFR 876.5540510(k) required10 decisions since 19830 recalls

10 FDA decisions since 1983. 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 KNZ 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 · KNZ

FDA has decided no KNZ device since 2007.

Median 510(k) review, days · KNZ

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

Recalls per year · KNZ

No recall names KNZ since 2007.

Adverse event reports per year · KNZ

2in 2021

2017: 12018: 12021: 2
2007high 2 (2021) · low 0 (2007)2025

MAUDE reports naming product code KNZ, 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—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—01
20190—00
20200—00
20210—02
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — KNZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KNZ? 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 876.5540.