510(k) · Cleared
ClearedModification to Nitrex Nitinol Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 2, 2004 as substantially equivalent to K893626 (Flexmedics, 1989) and 4 other predicates after a 19-day review. Its family tree reaches back 3 generations to 1997. 11 later devices descend from it.
- Decided
- Mar 2, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K970376 (1997). 8 ancestors in all, the oldest K893626 (1989). 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 2 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 1 generation backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- This deviceK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- Descendant · 2 generations on · 9 of its ownK060551 Brivant GuidewireBrivant Limited · 2006
- Descendant · 3 generations on · 3 of its ownK083094 Streamer Polymer GuidewireBrivant, Ltd. · 2009
- Descendant · 3 generations on · 2 of its ownK103377 Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK160643 ENROUTE 0.014 GuidewireLake Region Medical · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K050756Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005 · cites it directly10descendants
- K060551Brivant GuidewireBrivant Limited · 2006 · 2 generations on9descendants
- K083094Streamer Polymer GuidewireBrivant, Ltd. · 2009 · 3 generations on3descendants
- K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011 · 3 generations on2descendants
- K160643ENROUTE 0.014 GuidewireLake Region Medical · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −2 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −1 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| 0 (this device) | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| +1 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| +2 | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| +3 | K083094 | Streamer Polymer Guidewire | Brivant, Ltd. | 2009 | — |
| +3 | K103377 | Charter Guidewire Model 45-281, 45-282, 45-283 | Brivant, Ltd. | 2011 | — |
| +1 | K160643 | ENROUTE 0.014 Guidewire | Lake Region Medical | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K893626 | Flexmedics GuidewireSummary page 1…rson Regulatory Affairs Specialist 763-398-7487 PREDICATE FlexFinder Guidewire (K893626, K943390) Nitrex Nitinol Guidewire (K024021, K031864) Lake Regi… | 1989 |
| * | K943390 | Flexfinder GuidewireSummary page 1…Regulatory Affairs Specialist 763-398-7487 PREDICATE FlexFinder Guidewire (K893626, K943390) Nitrex Nitinol Guidewire (K024021, K031864) Lake Region Manufa… | 1995 |
| * | K024021 | Nitrex Nitinol GuidewireSummary page 1…763-398-7487 PREDICATE FlexFinder Guidewire (K893626, K943390) Nitrex Nitinol Guidewire (K024021, K031864) Lake Region Manufacturing, Inc. (K022813) DEVICE The guidewi… | 2003 |
| * | K031864 | Nitrex Nitinol GuidewireSummary page 1…763-398-7487 PREDICATE FlexFinder Guidewire (K893626, K943390) Nitrex Nitinol Guidewire (K024021, K031864) Lake Region Manufacturing, Inc. (K022813) DEVICE The guidewire is con… | 2003 |
| * | K022813 | Steerable GuidewireSummary page 1…idewire (K893626, K943390) Nitrex Nitinol Guidewire (K024021, K031864) Lake Region Manufacturing, Inc. (K022813) DEVICE The guidewire is constructed of nitinol (nickel-titaniumn alloy). DESCRIPTION… | 2003 |
What descends from it? (11)
See all 112 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 7 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K050756 (Invatec Innovative Technologies, S.R.L., 2005) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K893626.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040345: Modification to Nitrex Nitinol Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040345
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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