510(k) Report

510(k) · Cleared

Cleared

Ureteropyelogram Cath for Retrograde Dye Injection

K903994510(k) TraditionalCleared Oct 19, 199051-day reviewClass II21 CFR 876.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Urology, Inc. · FGF Catheter, Ureteral Disposable (X-Ray)

Cleared on Oct 19, 1990 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 19, 1990
Review
51 days
Class
Class II
Product code
FGF
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K903994Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FGF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FGF devices

FGF Catheter, Ureteral Disposable (X-Ray): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGF

FDA has decided no FGF device since 2007.

Median 510(k) review, days · FGF

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

Recalls per year · FGF

No recall names FGF since 2007.

Adverse event reports per year · FGF

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code FGF, 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—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Applied Urology, Inc.

13 FDA decisions under this applicant name. See the company

  • K921838Acucise Ureteral Cutting CatheterApplied Urology, Inc. · 1993
  • K925282Urological Catheter and AccessoriesApplied Urology, Inc. · 1993
  • K920695Ureteral StentApplied Urology, Inc. · 1992
  • K915219Urethral Electrode SheathApplied Urology, Inc. · 1992
  • K912093Disposable Aspiration Irrigation SystemApplied Urology, Inc. · 1992

https://510kreport.com/device/K903994 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903994: Ureteropyelogram Cath for Retrograde Dye Injection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903994

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026