510(k) · Cleared
Recalled · 2006Triactiv System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kensey Nash Corp. · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Mar 23, 2005 as substantially equivalent to K013913 (Medtronic Percusurge, Inc., 2002) after a 237-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 23, 2005
- Review
- 237 days
- Class
- Class II
- Product code
- NFA
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013913 (2002). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013913 Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemMedtronic Percusurge, Inc. · 2002
- This deviceK042040 Triactiv SystemKensey Nash Corp. · 2005
- Descendant · cites it directly · 3 of its ownK060651 Proxis System, Model EPS101St Jude Medical · 2006
- Descendant · 2 generations on · 1 of its ownK063638 Modification to Proxis System, Model Eps 101St Jude Medical · 2007
- Descendant · cites it directly · 1 of its ownK061772 Triactiv FX Embolic Protection SystemKensey Nash Corp. · 2006 · Recalled
- Descendant · 3 generations on · 0 of its ownK073700 6F Proxis SystemSt. Jude Medical, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK073563 Modification to Proxis SystemSt Jude Medical · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060651Proxis System, Model EPS101St Jude Medical · 2006 · cites it directly3descendants
- K063638Modification to Proxis System, Model Eps 101St Jude Medical · 2007 · 2 generations on1descendant
- K061772Triactiv FX Embolic Protection SystemKensey Nash Corp. · 2006 · cites it directly1descendant
- K0737006F Proxis SystemSt. Jude Medical, Inc. · 2008 · 3 generations on0descendants
- K073563Modification to Proxis SystemSt Jude Medical · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration System | Medtronic Percusurge, Inc. | 2002 | — |
| 0 (this device) | K042040 | Triactiv System | Kensey Nash Corp. | 2005 | — |
| +1 | K060651 | Proxis System, Model EPS101 | St Jude Medical | 2006 | — |
| +2 | K063638 | Modification to Proxis System, Model Eps 101 | St Jude Medical | 2007 | — |
| +1 | K061772 | Triactiv FX Embolic Protection System | Kensey Nash Corp. | 2006 | 3 |
| +3 | K073700 | 6F Proxis System | St. Jude Medical, Inc. | 2008 | — |
| +2 | K073563 | Modification to Proxis System | St Jude Medical | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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 NFA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemSummary page 6…on Kensey Nash Corporation considers the TriActiv® System to be substantially equivalent to the predicate device GuardWire® Temporary Occlusion and Aspiration System (K013913) legally marketed by Medtronic AVE based on its intended use, target population, technical features and the results on non-clini… | 2002 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| May 24, 2006 | Not classified | Z-1219-06 | Other | Volume control knob not able to go up to larger diameters |
| May 24, 2006 | Not classified | Z-1221-06 | Other | volume control knob not able to go up to larger diameters |
| May 24, 2006 | Not classified | Z-1220-06 | Other | volume control knob not able to go up to larger diameters |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NFA devicesNFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFA
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NFA
Too few NFA 510(k)s in any year since 2007 to give a median.
Recalls per year · NFA
No recall names NFA since 2007.
Adverse event reports per year · NFA
91in 2025
MAUDE reports naming product code NFA, 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 | 1 | — | 0 | 110 |
| 2008 | 2 | — | 0 | 80 |
| 2009 | 0 | — | 0 | 104 |
| 2010 | 0 | — | 0 | 183 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 55 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 42 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 63 |
| 2017 | 0 | — | 0 | 50 |
| 2018 | 0 | — | 0 | 78 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 55 |
| 2025 | 0 | — | 0 | 91 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TriActiv® System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0m to 5.0mm in diameter. The TriActiv® System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042040 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042040: Triactiv System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042040
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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