510(k) · Cleared
ClearedBrivant Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brivant Limited · DQX Wire, Guide, Catheter
Cleared on Jun 7, 2006 as substantially equivalent to K050756 (Invatec Innovative Technologies, S.R.L., 2005) and 2 other predicates after a 97-day review. Its family tree reaches back 5 generations to 1997. 9 later devices descend from it.
- Decided
- Jun 7, 2006
- Review
- 97 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K970376 (1997). 12 ancestors in all, the oldest K893626 (1989). 9 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 4 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 3 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 2 generations backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- 1 generation backK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- This deviceK060551 Brivant GuidewireBrivant Limited · 2006
- Descendant · cites it directly · 3 of its ownK083094 Streamer Polymer GuidewireBrivant, Ltd. · 2009
- Descendant · cites it directly · 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
- Descendant · cites it directly · 1 of its ownK102211 Cruiser 18 GuidewireBrivant, Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK253746 Enroute 0.014'' Transcarotid GuidewireLake Region Medical · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K083094Streamer Polymer GuidewireBrivant, Ltd. · 2009 · cites it directly3descendants
- K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011 · cites it directly2descendants
- K160643ENROUTE 0.014 GuidewireLake Region Medical · 2016 · cites it directly1descendant
- K102211Cruiser 18 GuidewireBrivant, Ltd. · 2010 · cites it directly1descendant
- K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −4 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −3 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −2 | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| −1 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| 0 (this device) | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| +1 | K083094 | Streamer Polymer Guidewire | Brivant, Ltd. | 2009 | — |
| +1 | K103377 | Charter Guidewire Model 45-281, 45-282, 45-283 | Brivant, Ltd. | 2011 | — |
| +1 | K160643 | ENROUTE 0.014 Guidewire | Lake Region Medical | 2016 | — |
| +1 | K102211 | Cruiser 18 Guidewire | Brivant, Ltd. | 2010 | — |
| +2 | K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K050756 | Skipper and Skipper Race GuidewireSummary page 1…#t Manufacturer Device 510(k) No. 1 Invatec Innovative SKIPPER and SKIPPER RACE K050756 Technologies Guidewires 2 Biosphere Medical Inc. Segway GT SEG1812 K0… | 2005 |
| * | K011287 | Radius Cougar WireSummary page 1…and SKIPPER RACE K050756 Technologies Guidewires 2 Biosphere Medical Inc. Segway GT SEG1812 K011287 K032129 This summary is provided incompliance wit… | 2001 |
| * | K032129 | Radius 018 Cougar WireSummary page 1…res 2 Biosphere Medical Inc. Segway GT SEG1812 K011287 K032129 This summary is provided incompliance with section 513(i)(3)(a) of the Act and summarizes the safety and effectiveness informati… | 2003 |
What descends from it? (9)
5 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 9 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K083094 (Brivant, Ltd., 2009) has gone furthest, with 3 descendants of its own.
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?
Brivant guidewires are intended for use in the coronary and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060551: Brivant Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060551
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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