510(k) Report

510(k) · Cleared

Cleared

Proxis Flow-Control Device, Models Eps 101, IC 101

K023548510(k) TraditionalCleared Aug 4, 2003286-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Velocimed · DQY Catheter, Percutaneous

Cleared on Aug 4, 2003 as substantially equivalent to K001917 (Arteria Medical Science, Inc., 2001) and 4 other predicates after a 286-day review. Its family tree reaches back 1 generation to 1991. 6 later devices descend from it.

Decided
Aug 4, 2003
Review
286 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K913517 (1991). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor2005: 1 descendant cleared2006: 2 descendants cleared2007: 1 descendant cleared2008: 2 descendants clearedK913517 · Isolate Infusion Cathetr System · Lake Region Mfg., Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K913517 · Isolate Infusion Cathetr System · Lake Region Mfg., Inc. · 19910
  1. Root · 1 generation backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
  2. This deviceK023548 Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed · 2003
  3. Descendant · cites it directly · 5 of its ownK042117 Proxis System, Model Eps 101Velocimed, Inc. · 2005
  4. Descendant · 2 generations on · 3 of its ownK060651 Proxis System, Model EPS101St Jude Medical · 2006
  5. Descendant · 2 generations on · 2 of its ownK052523 Proxis SystemVelocimed, Inc. · 2006
  6. Descendant · 2 generations on · 1 of its ownK063638 Modification to Proxis System, Model Eps 101St Jude Medical · 2007
  7. Descendant · 3 generations on · 0 of its ownK073700 6F Proxis SystemSt. Jude Medical, Inc. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 12008: 2
2005high 2 (2006) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K042117Proxis System, Model Eps 101Velocimed, Inc. · 2005 · cites it directly5descendants
  • K060651Proxis System, Model EPS101St Jude Medical · 2006 · 2 generations on3descendants
  • K052523Proxis SystemVelocimed, Inc. · 2006 · 2 generations on2descendants
  • K063638Modification to Proxis System, Model Eps 101St Jude Medical · 2007 · 2 generations on1descendant
  • K0737006F Proxis SystemSt. Jude Medical, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913517Isolate Infusion Cathetr SystemLake Region Mfg., Inc.1991—
0 (this device)K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed2003—
+1K042117Proxis System, Model Eps 101Velocimed, Inc.2005—
+2K060651Proxis System, Model EPS101St Jude Medical2006—
+2K052523Proxis SystemVelocimed, Inc.2006—
+2K063638Modification to Proxis System, Model Eps 101St Jude Medical2007—
+3K0737006F Proxis SystemSt. Jude Medical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200710
200820
FIG. 1 — Lineage of K023548, 1991–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K001917Parodi Catheter for Angiography (Parca)
Summary page 2
…egally marketed Occlusion Balloon Catheters. Specifically, the Proxis Flow-Control device is substantially equivalent to the Parodi Catheter for Angiography (K 00 1917), the Equinox Occlusion Balloon Catheter (K 990487), the 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coron…
Arteria Medical Science, Inc.2001—
*K990487Equinox Occlusion Balloon System
Summary page 1
…Minneapolis, MN 55369 2.2 Predicate Devices The Proxis Flow-Control Device is substantially equivalent to the Equinox Occlusion Balloon Catheter (K 990487), 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K9326 16), and the Isolate Inf…
Micro Therapeutics, Inc.1999—
*K9526384.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the…
Summary page 1
…The Proxis Flow-Control Device is substantially equivalent to the Equinox Occlusion Balloon Catheter (K 990487), 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K9326 16), and the Isolate Infusion Catheter (K9 13517). 2.3 Indication for use…
Baxter Edwards1995—
*K932616Scimed (R) Dispatch (TM) Coronary Infusion Catheter
Summary page 1
…ntially equivalent to the Equinox Occlusion Balloon Catheter (K 990487), 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K9326 16), and the Isolate Infusion Catheter (K9 13517). 2.3 Indication for use The Proxis Flow-Control device controls the…
Scimed Life Systems, Inc.1993—
*K913517Isolate Infusion Cathetr System
Summary page 1
…lloon Catheter (K 990487), 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K9326 16), and the Isolate Infusion Catheter (K9 13517). 2.3 Indication for use The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery…
Lake Region Mfg., Inc.1991—

Also cleared against K001917: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042117Proxis System, Model Eps 101Velocimed, Inc.20055

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K042117 (Velocimed, Inc., 2005) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K001917.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Proxis Flow-Control device 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.

Also cleared against K001917

1 other device cites the same predicate.

  • K070770Gore Balloon SheathW. L. Gore & Associates, Inc. · 2007

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K023548 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023548: Proxis Flow-Control Device, Models Eps 101, IC 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023548

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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