510(k) · Cleared
ClearedKadir HI-Torque Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Corp. · KOD Catheter, Urological
Cleared on Apr 10, 1987 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 105 devices in its family, counting itself, have a Class I recall. 104 later devices descend from it.
- Decided
- Apr 10, 1987
- Review
- 10 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 0
104 later devices descend from it, 1 citing it directly. 7 of the 105 devices in this family, counting this one, have a Class I recall.
- This deviceK871297 Kadir HI-Torque Guide WireArgon Medical Corp. · 1987
- Descendant · cites it directly · 103 of its ownK963320 TFX Medical GuidewireTfx Medical Group · 1996
- Descendant · 2 generations on · 89 of its ownK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
- Descendant · 3 generations on · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- Descendant · 3 generations on · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- Descendant · 4 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 104 · See all- K963320TFX Medical GuidewireTfx Medical Group · 1996 · cites it directly103descendants
- K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001 · 2 generations on89descendants
- K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · 3 generations on80descendants
- K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · 3 generations on37descendants
- K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871297 | Kadir HI-Torque Guide Wire | Argon Medical Corp. | 1987 | — |
| +1 | K963320 | TFX Medical Guidewire | Tfx Medical Group | 1996 | — |
| +2 | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2001 | — |
| +3 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| +3 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| +4 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 5 | 2 |
| 2019 | 5 | 1 |
| 2020 | 3 | 0 |
| 2021 | 3 | 1 |
| 2022 | 2 | 1 |
| 2023 | 3 | 0 |
| 2024 | 5 | 1 |
| 2025 | 7 | 0 |
| 2026 | 8 | 0 |
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.
7 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963320 | TFX Medical Guidewire | 1996 | 103 |
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 7 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 9 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 9 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K963320 (Tfx Medical Group, 1996) has gone furthest, with 103 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 | — |
https://510kreport.com/device/K871297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K871297: Kadir HI-Torque Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871297
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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