510(k) · Cleared
ClearedModification to Proxis System, Model Eps 101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQY Catheter, Percutaneous
Cleared on May 11, 2007 as substantially equivalent to K042117 (Velocimed, Inc., 2005) and 1 other predicate after a 155-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- May 11, 2007
- Review
- 155 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913517 (1991). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 3 generations backK023548 Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003
- 2 generations backK042117 Proxis System, Model Eps 101Velocimed, Inc. · 2005
- 1 generation backK060651 Proxis System, Model EPS101St Jude Medical · 2006
- This deviceK063638 Modification to Proxis System, Model Eps 101St Jude Medical · 2007
- Descendant · cites it directly · 0 of its ownK073700 6F Proxis SystemSt. Jude Medical, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K0737006F Proxis SystemSt. Jude Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −3 | K023548 | Proxis Flow-Control Device, Models Eps 101, IC 101 | Velocimed | 2003 | — |
| −2 | K042117 | Proxis System, Model Eps 101 | Velocimed, Inc. | 2005 | — |
| −1 | K060651 | Proxis System, Model EPS101 | St Jude Medical | 2006 | — |
| 0 (this device) | K063638 | Modification to Proxis System, Model Eps 101 | St Jude Medical | 2007 | — |
| +1 | K073700 | 6F Proxis System | St. Jude Medical, Inc. | 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 |
|---|---|---|
| 2008 | 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.
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? (2)
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 2…Flow Control System device covered by this submission is identical in function, mechanism of action and intended use as the market cleared rapid-exchange Proxis System (K042117). In addition, the technological characteristics and ability to control fluid flow are identical to the over-the-wire Proxis Syst… | 2005 |
| * | K060651 | Proxis System, Model EPS101Summary page 2…mbolic protection. Predicate Device Comparison / Technological Characteristics The Proxis Flow Control System, a modification of the current over-the-wire Proxis System (K060651), was created by decreasing the diameter of the catheter and sealing balloon. The Proxis Flow Control System device covered by th… | 2006 |
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 |
|---|---|---|---|
| K073700 | 6F Proxis System | 2008 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K073700 (St. Jude Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042117.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Flow Control system controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a 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 System is not indicated for use for embolic protection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063638: Modification to 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/K063638
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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