510(k) · Cleared
Recalled · 2008Dual Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Mar 3, 2005 as substantially equivalent to K930483 (Surgitek, 1993) after a 65-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 3, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- EYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930483 (1993). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930483 | Ureteral Catheter | Surgitek | 1993 | — |
| 0 (this device) | K043581 | Dual Lumen Catheter | Acmi Corporation | 2005 | — |
| +1 | K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access… | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K930483 | Ureteral CatheterSummary page 1…Dual Lumen Catheter Generic/Common Name: Ureteral Catheter Predicate Device Ureteral Catheter K930483 (The Flexible Tip (open or closed) Ureteral Catheter) Intended Uses Dual Lumen Catheter has multiple uses, including ureter… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2008 | Not classified | Z-2226-2008 | Process control | Particulate matter in the catheter |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K180182 (Cook Incorporated, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EYB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EYB
248in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EYB
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EYB
11in 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 dual lumen ureteral catheter is designed for percutaneous and transurethral access and is indicated as a conduit for multiple uses including, but not limited to, ureteral dilation, stone displacement, delivery of contrast material/anesthetic agents and guidewire placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043581: Dual Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043581
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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