510(k) Report

FDA product code · Gastroenterology and urology

Tubing, Dialysate

FIDClass II21 CFR 876.5820510(k) required3 decisions since 19770 recalls

3 FDA decisions since 1977. 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 FID 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 · FID

FDA has decided no FID device since 2007.

Median 510(k) review, days · FID

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

Recalls per year · FID

No recall names FID since 2007.

Adverse event reports per year · FID

1in 2019

2008: 22012: 12019: 1
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code FID, 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—02
20090—00
20100—00
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — FID by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FID? 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 876.5820.