510(k) · Cleared
ClearedProxis System, Model Eps 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velocimed, Inc. · DQY Catheter, Percutaneous
Cleared on Jan 7, 2005 as substantially equivalent to K023548 (Velocimed, 2003) after a 155-day review. Its family tree reaches back 2 generations to 1991. 5 later devices descend from it.
- Decided
- Jan 7, 2005
- Review
- 155 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913517 (1991). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 1 generation backK023548 Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003
- This deviceK042117 Proxis System, Model Eps 101Velocimed, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK060651 Proxis System, Model EPS101St Jude Medical · 2006
- Descendant · cites it directly · 2 of its ownK052523 Proxis SystemVelocimed, Inc. · 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 · 2 generations on · 0 of its ownK073563 Modification to Proxis SystemSt Jude Medical · 2008
Most influential descendants
Showing 5 of 5 · See all- K060651Proxis System, Model EPS101St Jude Medical · 2006 · cites it directly3descendants
- K052523Proxis SystemVelocimed, Inc. · 2006 · cites it directly2descendants
- K063638Modification to Proxis System, Model Eps 101St Jude Medical · 2007 · cites it directly1descendant
- K0737006F Proxis SystemSt. Jude Medical, Inc. · 2008 · 2 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 |
|---|---|---|---|---|---|
| −2 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −1 | K023548 | Proxis Flow-Control Device, Models Eps 101, IC 101 | Velocimed | 2003 | — |
| 0 (this device) | K042117 | Proxis System, Model Eps 101 | Velocimed, Inc. | 2005 | — |
| +1 | K060651 | Proxis System, Model EPS101 | St Jude Medical | 2006 | — |
| +1 | K052523 | Proxis System | Velocimed, Inc. | 2006 | — |
| +1 | K063638 | Modification to Proxis System, Model Eps 101 | St Jude Medical | 2007 | — |
| +2 | K073700 | 6F Proxis System | St. Jude Medical, Inc. | 2008 | — |
| +2 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K023548 | Proxis Flow-Control Device, Models Eps 101, IC 101Summary page 1…roxis System without hydrophilic coating (predicate device) which had been found to be substantially equivalent through the 5 10(k) notification process (K023 548). The Proxis System with hydrophilic coating is the same as the predicate device except for the addition of the… | 2003 |
What descends from it? (5)
3 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 14 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K060651 (St Jude Medical, 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Proxis System controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042117 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042117: Proxis System, Model Eps 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042117
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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