510(k) · Cleared
ClearedspeX Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflow Medical · DQY Catheter, Percutaneous
Cleared on Feb 19, 2020 as substantially equivalent to K173662 (Reflow Medical, Inc., 2017) after a 113-day review. Its family tree reaches back 10 generations to 2000. 1 of the 31 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Feb 19, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001992 (2000). 28 ancestors in all, the oldest K935425 (1994). 2 later devices descend from it, 1 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations between
- 3 generations backK112035 Valet Micro CatheterVolcano Corporation · 2012
- 2 generations backK141649 Spex Support CatheterReflow Medical · 2014
- 1 generation backK173662 speX Support CatheterReflow Medical, Inc. · 2017
- This deviceK193012 speX Support CatheterReflow Medical · 2020
- Descendant · cites it directly · 1 of its ownK201811 coraForce and coraFlex Support CathetersReflow Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK251277 CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 9 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 8 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 7 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 6 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 5 generations backK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- 4 generations backK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- 3 generations backK112035 Valet Micro CatheterVolcano Corporation · 2012
- 2 generations backK141649 Spex Support CatheterReflow Medical · 2014
- 1 generation backK173662 speX Support CatheterReflow Medical, Inc. · 2017
- This deviceK193012 speX Support CatheterReflow Medical · 2020
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…4 generations back · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −9 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −8 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −7 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −6 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −5 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| −4 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| −3 | K112035 | Valet Micro Catheter | Volcano Corporation | 2012 | — |
| −2 | K141649 | Spex Support Catheter | Reflow Medical | 2014 | — |
| −1 | K173662 | speX Support Catheter | Reflow Medical, Inc. | 2017 | — |
| 0 (this device) | K193012 | speX Support Catheter | Reflow Medical | 2020 | — |
| +1 | K201811 | coraForce and coraFlex Support Catheters | Reflow Medical, Inc. | 2020 | — |
| +2 | K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K173662 | speX Support CatheterSummary page 4…Percutaneous Catheter Regulatory Class: 2 Product Code: DQY III. PREDICATE DEVICE speX Support Catheter (K173662) This predicate has not been subject to a design-related recall IV. DEVICE DESCRIPTION… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201811 | coraForce and coraFlex Support Catheters | 2020 | 1 |
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 · 4 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 28 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K201811 (Reflow Medical, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K173662.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193012: speX Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193012
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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