510(k) Report

510(k) · Decided

Decided

Ureteral Catheter

K930483510(k) TraditionalDecided Jul 16, 1993168-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

Surgitek · EYB Catheter, Ureteral, Gastro-Urology

Cleared on Jul 16, 1993 after a 168-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 16, 1993
Review
168 days
Class
Class II
Product code
EYB
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2018: 1 descendant cleared1990200020102020
  1. This deviceK930483 Ureteral CatheterSurgitek · 1993
  2. Descendant · cites it directly · 1 of its ownK043581 Dual Lumen CatheterAcmi Corporation · 2005 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK180182 Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral…Cook Incorporated · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K043581Dual Lumen CatheterAcmi Corporation · 2005 · cites it directly1descendant
  • K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930483Ureteral CatheterSurgitek1993—
+1K043581Dual Lumen CatheterAcmi Corporation20051
+2K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access…Cook Incorporated2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201810
FIG. 1 — Lineage of K930483, 1993–2018Source: FDA 510(k) summaries, read by 510(k) Report · 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 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. #1 K192183 RocaTub Ureteral Catheterscore -0.2 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K043581Dual Lumen CatheterAcmi Corporation20051

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?

  • Of its descendants, K043581 (Acmi Corporation, 2005) has gone furthest, with 1 descendant of its own.

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

2009: 12010: 12014: 12017: 12018: 22019: 32020: 1
2007high 3 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EYB

248in 2019

2019: 248 days median
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

2008: 12022: 12026 (partial year): 2
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

2007: 142008: 152009: 422010: 132011: 112012: 102013: 142014: 92015: 92016: 42017: 102018: 82019: 222020: 132021: 112022: 52023: 232024: 122025: 11
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—014
20080—115
20091—042
20101—013
20110—011
20120—010
20130—014
20141—09
20150—09
20160—04
20171—010
20182—08
20193248022
20201—013
20210—011
20220—15
20230—023
20240—012
20250—011
20260—2—

More from Surgitek

29 FDA decisions under this applicant name. See the company

  • K946296Quadra-Coil Ureteral StentSurgitek · 1995
  • K944391OM-4 (Tenative) Urodynamic Measruement SystemSurgitek · 1995
  • K943491Right Angle Urologic Laser FiberSurgitek · 1994
  • K941952Surgitek InfuserSurgitek · 1994
  • K933260Helical Stone/Flatwire Stone BasketsSurgitek · 1994

Recent decisions in EYB

The EYB category page

  • K192183RocaTub Ureteral CatheterPromepal Sam · 2020
  • K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc. · 2019
  • K183323UPJ Occlusion Balloon CatheterCook Incorporated · 2019
  • K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated · 2019
  • K182122Ureteric CathetersColoplast Corp. · 2018

https://510kreport.com/device/K930483 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930483: Ureteral Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930483

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