510(k) · Cleared
ClearedFlowGuide (FG60F); GuidionShort (GS60F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imds Operations B.V. · DQY Catheter, Percutaneous
Cleared on Apr 17, 2025 as substantially equivalent to K210110 (Imds Operations B.V., 2021) after a 253-day review. Its family tree reaches back 10 generations to 1994. 1 of the 17 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 17, 2025
- Review
- 253 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K935425 (1994). 16 ancestors in all. No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 6 generations between
- 3 generations backK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · Recalled
- 2 generations backK172090 GuideLiner V3 CatheterVascular Solutions, Inc. · 2017
- 1 generation backK210110 GuidionImds Operations B.V. · 2021
- This deviceK242337 FlowGuide (FG60F); GuidionShort (GS60F)Imds Operations B.V. · 2025
Show all 10 generations
- Root · 10 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 9 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 8 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 7 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 6 generations backK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
- 5 generations backK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- 4 generations backK091750 Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009
- 3 generations backK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011 · Recalled
- 2 generations backK172090 GuideLiner V3 CatheterVascular Solutions, Inc. · 2017
- 1 generation backK210110 GuidionImds Operations B.V. · 2021
- This deviceK242337 FlowGuide (FG60F); GuidionShort (GS60F)Imds Operations B.V. · 2025
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…6 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −9 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −8 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −7 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −6 | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| −5 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| −4 | K091750 | Guideliner Catheter, Models 5571, 5572, 5573 | Vascular Solutions, Inc. | 2009 | — |
| −3 | K112082 | Guideliner V2 Catheter | Vascular Solutions, Inc. | 2011 | 1 |
| −2 | K172090 | GuideLiner V3 Catheter | Vascular Solutions, Inc. | 2017 | — |
| −1 | K210110 | Guidion | Imds Operations B.V. | 2021 | — |
| 0 (this device) | K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K210110 | GuidionSummary page 5…Classification Name Catheter, percutaneous Product Code DQY Predicate Device K210110, Guidion Rapid Exchange Guide Extension Catheter, IMDS Operations B.V.… | 2021 |
| † | K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 6 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242337: FlowGuide (FG60F); GuidionShort (GS60F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242337
Report an extraction error
Are you the manufacturer?
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