510(k) · Cleared
ClearedProxis System, Model EPS101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cleared on Sep 13, 2006 as substantially equivalent to K042117 (Velocimed, Inc., 2005) and 4 other predicates after a 184-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 13, 2006
- Review
- 184 days
- Class
- Class II
- Product code
- NFA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K913517 (1991). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 2 generations backK023548 Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003
- 1 generation backK042117 Proxis System, Model Eps 101Velocimed, Inc. · 2005
- This deviceK060651 Proxis System, Model EPS101St Jude Medical · 2006
- Descendant · cites it directly · 1 of its ownK063638 Modification to Proxis System, Model Eps 101St Jude Medical · 2007
- Descendant · 2 generations on · 0 of its ownK073700 6F Proxis SystemSt. Jude Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK073563 Modification to Proxis SystemSt Jude Medical · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −2 | K023548 | Proxis Flow-Control Device, Models Eps 101, IC 101 | Velocimed | 2003 | — |
| −1 | K042117 | Proxis System, Model Eps 101 | Velocimed, Inc. | 2005 | — |
| 0 (this device) | K060651 | Proxis System, Model EPS101 | St Jude Medical | 2006 | — |
| +1 | K063638 | Modification to Proxis System, Model Eps 101 | St Jude Medical | 2007 | — |
| +2 | K073700 | 6F Proxis System | St. Jude Medical, Inc. | 2008 | — |
| +1 | K073563 | Modification to Proxis System | St Jude Medical | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K042117 | Proxis System, Model Eps 101Summary page 1…r use as an embolic protection system. This Proxis System is physically identical to the predicate Proxis System, which is market cleared for a Flow Control indication (K0421 17) with the exception of three primary design modifications. The three primary changes include: Proxis catheter type changed from '… | 2005 |
| * | K023691 | Boston Scientific Filterwire EX EmbolicSummary page 1…ouble Y-adaptor to a single Y-adaptor. The Proxis System is similar in function and intended use to market cleared predicate ermbolic protection systems: the FilterWire (K02369 1), GuardWire Temporary Occlusion and Aspiration System (K023878) and TriActiv (K042040). 1.2.2. DEVIcE DESCRI… | 2003 |
| * | K023878 | Guardwire Temporary Occlusion and Aspiration SystemSummary page 2…and intended use to market cleared predicate ermbolic protection systems: the FilterWire (K02369 1), GuardWire Temporary Occlusion and Aspiration System (K023878) and TriActiv (K042040). 1.2.2. DEVIcE DESCRIPTION The Proxis System is a proximal embolic protection system used in conjunc… | 2003 |
| * | K042040 | Triactiv SystemSummary page 2…ket cleared predicate ermbolic protection systems: the FilterWire (K02369 1), GuardWire Temporary Occlusion and Aspiration System (K023878) and TriActiv (K042040). 1.2.2. DEVIcE DESCRIPTION The Proxis System is a proximal embolic protection system used in conjunction with other interve… | 2005 |
| * | K013913 | Percusurge Guardwire Plus Temporary Occlusion and Aspiration SystemSummary page 3…edicate devices that have similar indications, i.e. FilterWire EX Embolic Protection System (K023691) and PercuSurge GuardWire Temporary Occlusion and Aspiration System (K013913) and the Kensey Nash TriActiv (K042040). The primary difference in technologies to the predicate devices is that the Proxis Syste… | 2002 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K063638 (St Jude Medical, 2007) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K042117.
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 Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm -5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.
The Proxis System is also indicated to control the flow of fluids in the coronary and peripheral vasculature.
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/K060651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060651: Proxis System, Model EPS101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060651
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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