510(k) · Cleared
Recalled · 2012Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KOD Catheter, Urological
Cleared on Jul 13, 2001 as substantially equivalent to K965229 (Boston Scientific Corp, 1997) after an 18-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 13, 2001
- Review
- 18 days
- Class
- Class II
- Product code
- KOD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965229 (1997). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK965229 Imager Torque CatheterBoston Scientific Corp · 1997
- This deviceK011965 Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001
- Descendant · cites it directly · 4 of its ownK090270 Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK103349 Backstop CatheterPluromed, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK102527 Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque…Boston Scientific Corporation · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK110491 Backstop CatheterPluromed, Inc. · 2011
- Descendant · 4 generations on · 1 of its ownK180354 UroGen Ureteral CatheterUrogen Pharma, Ltd. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K090270Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 2009 · cites it directly4descendants
- K103349Backstop CatheterPluromed, Inc. · 2011 · 2 generations on3descendants
- K102527Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip…Boston Scientific Corporation · 2010 · cites it directly3descendants
- K110491Backstop CatheterPluromed, Inc. · 2011 · 3 generations on2descendants
- K180354UroGen Ureteral CatheterUrogen Pharma, Ltd. · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965229 | Imager Torque Catheter | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K011965 | Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 | Boston Scientific Corp | 2001 | — |
| +1 | K090270 | Backstop Catheter, Model 60-0000-3100 | Pluromed, Inc. | 2009 | — |
| +2 | K103349 | Backstop Catheter | Pluromed, Inc. | 2011 | — |
| +1 | K102527 | Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter… | Boston Scientific Corporation | 2010 | 1 |
| +3 | K110491 | Backstop Catheter | Pluromed, Inc. | 2011 | — |
| +4 | K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2018 | 4 | 0 |
| 2021 | 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 KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K965229 | Imager Torque CatheterSummary page 1…substantially equivalent to other urological catheters classificd under 21 CFR 876.5130, more specifically with Boston Scicntific Corporation's Tmager Torque Catheter (IK965229). ‘The substantial equivalence determination is based upon test tesults that confirm the praposed device is biocompatible and sub… | 1997 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2012 | Not classified | Z-1393-2012 | Package design/selection | Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in… |
| Oct 22, 2009 | Not classified | Z-0337-2010 | Packaging process control | The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Microvasive ® Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material.
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/K011965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011965: Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011965
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026