510(k) · Cleared

Cleared

Applied Ureteral Catheter

K020577510(k) TraditionalCleared May 22, 200290-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 Medical Resources Corp. · EYB Catheter, Ureteral, Gastro-Urology

Cleared on May 22, 2002 as substantially equivalent to K923729 (Cook Urological, Inc., 1993) after a 90-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: May 22, 2002
Review: 90 days
Class: Class II
Product code: EYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923729 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923729 Ureteral CatheterCook Urological, Inc. · 1993
This deviceK020577 Applied Ureteral CatheterApplied Medical Resources Corp. · 2002
Descendant · cites it directly · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923729	Ureteral Catheter	Cook Urological, Inc.	1993	—
0 (this device)	K020577	Applied Ureteral Catheter	Applied Medical Resources Corp.	2002	—
+1	K061661	Sta Cath Attachable Infision Catheter, Model STA20	Advanced Infusion, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K020577, 1993–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Top candidate predicates for a new EYB device

#1 K192183 RocaTub Ureteral Catheterscore -0.2 · 3 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K923729	Ureteral Catheter Summary page 1 …eteral, Gastro-Urology (Regulation Number 21CFR 876.5130, Urological catheter and accessories) Applied Ureteral Catheter Pigtail Ureteral Catheter (Ureteral Catheter, K923729), Cook Urological Inc., Spencer, IN. INTENDED USE STATEMENT: The Applied Ureteral Catheter is indicated for use in the urinary t…	Cook Urological, Inc.	1993	—

Also cleared against K923729: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061661	Sta Cath Attachable Infision Catheter, Model STA20	Advanced Infusion, Inc.	2006	0

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.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K061661 (Advanced Infusion, Inc., 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K923729.

How does its category compare?

All EYB devices

EYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EYB

1in 2020

2007high 3 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EYB

248in 2019

2007high 248 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EYB

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EYB

11in 2025

2007high 42 (2009) · low 4 (2016)2025

MAUDE reports naming product code EYB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	14
2008	0	—	1	15
2009	1	—	0	42
2010	1	—	0	13
2011	0	—	0	11
2012	0	—	0	10
2013	0	—	0	14
2014	1	—	0	9
2015	0	—	0	9
2016	0	—	0	4
2017	1	—	0	10
2018	2	—	0	8
2019	3	248	0	22
2020	1	—	0	13
2021	0	—	0	11
2022	0	—	1	5
2023	0	—	0	23
2024	0	—	0	12
2025	0	—	0	11
2026	0	—	2	—

What is it indicated for?

The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020577 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020577: Applied Ureteral Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020577

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026