510(k) · Cleared
Recalled · 2012Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KOD Catheter, Urological
Cleared on Nov 5, 2010 as substantially equivalent to K011965 (Boston Scientific Corp, 2001) after a 64-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 5, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- KOD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K965229 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK965229 Imager Torque CatheterBoston Scientific Corp · 1997
- 1 generation backK011965 Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001 · Recalled
- This deviceK102527 Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque…Boston Scientific Corporation · 2010
- Descendant · cites it directly · 1 of its ownK171600 Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK181144 Angled Tip Ureteral CatheterCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK180530 Imager II Urology Torque CatheterBoston Scientific Corporation · 2018
Most influential descendants
Showing 3 of 3 · See all- K171600Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated · 2018 · cites it directly1descendant
- K181144Angled Tip Ureteral CatheterCook Incorporated · 2018 · 2 generations on0descendants
- K180530Imager II Urology Torque CatheterBoston Scientific Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965229 | Imager Torque Catheter | Boston Scientific Corp | 1997 | — |
| −1 | K011965 | Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 | Boston Scientific Corp | 2001 | 2 |
| 0 (this device) | K102527 | Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter… | Boston Scientific Corporation | 2010 | — |
| +1 | K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018 | — |
| +2 | K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018 | — |
| +1 | K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 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 |
|---|---|---|---|
| * | K011965 | Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 | 2001 |
What descends from it? (3)
2 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K171600 (Cook Incorporated, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K011965.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 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. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop, intended for use in the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102527: Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip; Imager II Urology Torque Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102527
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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