510(k) · Cleared
ClearedCxi Triforce
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KRA Catheter, Continuous Flush
Cleared on Jul 25, 2011 as substantially equivalent to K072724 (Cook, Inc., 2007) and 2 other predicates after an 82-day review. Its family tree reaches back 6 generations to 2000. 1 of the 25 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 25, 2011
- Review
- 82 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001992 (2000). 23 ancestors in all, the oldest K810675 (1981). 1 later device descends from it, 1 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 5 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 4 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 3 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 2 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 1 generation backK082519 Finecross MG Coronary Micro-Guide CatheterTerumo Medical Corp. · 2008
- This deviceK111263 Cxi TriforceCook Incorporated · 2011
- Descendant · cites it directly · 0 of its ownK170931 CXI TriForce Peripheral Crossing SetCook Incorporated · 2017
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set4 generations back · 1981
Most influential descendants
Showing 1 of 1 · See all- K170931CXI TriForce Peripheral Crossing SetCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −5 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −4 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −3 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −2 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K082519 | Finecross MG Coronary Micro-Guide Catheter | Terumo Medical Corp. | 2008 | — |
| 0 (this device) | K111263 | Cxi Triforce | Cook Incorporated | 2011 | — |
| +1 | K170931 | CXI TriForce Peripheral Crossing Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 1 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
1 device in this family has 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K072724 | Cxi Support CatheterSummary page 1…er referred to as the CXITM TniForce) is substantially equivalent to the CXITM Support Catheter, manufactured by Cook Incorporated, which is cleared under 5 10(k) number K072724. The CXITM TniForce is also substantially equivalent to the FineCrossiM MG Coronary Micro-Guide Catheter and the GlidesheathTM, m… | 2007 |
| * | K082519 | Finecross MG Coronary Micro-Guide CatheterSummary page 1…equivalent to the FineCrossiM MG Coronary Micro-Guide Catheter and the GlidesheathTM, manufactured by Terumo Medical Corporation, which are cleared under 5 10(k) numbers K082519 and K102008, respectively. 4. Comparison to Predicate Device: It has been demonstrated that the CXITM TniForce is comparable to… | 2008 |
| * | K102008 | GlidesheathSummary page 1…o the FineCrossiM MG Coronary Micro-Guide Catheter and the GlidesheathTM, manufactured by Terumo Medical Corporation, which are cleared under 5 10(k) numbers K082519 and K102008, respectively. 4. Comparison to Predicate Device: It has been demonstrated that the CXITM TniForce is comparable to the predica… | 2010 |
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 |
|---|---|---|---|
| K170931 | CXI TriForce Peripheral Crossing Set | 2017 | 0 |
Has anything in its family been recalled? (1 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.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 4 generations back · ◆ in the 1981 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170931 (Cook Incorporated, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072724.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The CXI TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111263: Cxi Triforce.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111263
Report an extraction error
Are you the manufacturer?
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