510(k) · Cleared
ClearedImager Torque Catheter
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 Mar 4, 1997 after a 63-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Mar 4, 1997
- Review
- 63 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK965229 Imager Torque CatheterBoston Scientific Corp · 1997
- Descendant · cites it directly · 10 of its ownK011965 Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001 · Recalled
- Descendant · 2 generations on · 4 of its ownK090270 Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK103349 Backstop CatheterPluromed, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK102527 Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque…Boston Scientific Corporation · 2010 · Recalled
- Descendant · 4 generations on · 2 of its ownK110491 Backstop CatheterPluromed, Inc. · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K011965Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001 · cites it directly10descendants
- K090270Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 2009 · 2 generations on4descendants
- K103349Backstop CatheterPluromed, Inc. · 2011 · 3 generations on3descendants
- K102527Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip…Boston Scientific Corporation · 2010 · 2 generations on3descendants
- K110491Backstop CatheterPluromed, Inc. · 2011 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K090270 | Backstop Catheter, Model 60-0000-3100 | Pluromed, Inc. | 2009 | — |
| +3 | K103349 | Backstop Catheter | Pluromed, Inc. | 2011 | — |
| +2 | K102527 | Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter… | Boston Scientific Corporation | 2010 | 1 |
| +4 | K110491 | Backstop Catheter | Pluromed, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 112 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011965 (Boston Scientific Corp, 2001) has gone furthest, with 10 descendants of its own.
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 Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials.
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/K965229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965229: Imager Torque Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965229
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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