510(k) · Cleared
ClearedCruiser 18 Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brivant, Ltd. · DQX Wire, Guide, Catheter
Cleared on Sep 3, 2010 as substantially equivalent to K060551 (Brivant Limited, 2006) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Sep 3, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970376 (1997). 14 ancestors in all, the oldest K893626 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 5 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 4 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 3 generations backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- 2 generations backK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- 1 generation backK060551 Brivant GuidewireBrivant Limited · 2006
- This deviceK102211 Cruiser 18 GuidewireBrivant, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK120137 Victory Guidewire (32 Models)Brivant, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120137Victory Guidewire (32 Models)Brivant, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −5 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −4 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −3 | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| −2 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| −1 | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| 0 (this device) | K102211 | Cruiser 18 Guidewire | Brivant, Ltd. | 2010 | — |
| +1 | K120137 | Victory Guidewire (32 Models) | Brivant, Ltd. | 2012 | — |
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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K060551 | Brivant GuidewireSummary page 1…evices Manufacturer 510k Date Brivant Ltd, Brivant Guidewire K060551 07 Jun 2006 Brivant Ltd, Courier Guidewire K073082 09 Jan 2008 Princi… | 2006 |
| * | K073082 | CPS Courier GuidewireSummary page 1…Brivant Ltd, Brivant Guidewire K060551 07 Jun 2006 Brivant Ltd, Courier Guidewire K073082 09 Jan 2008 Principle of The Cruiser-lB Guidewire is operated manually by a manual process Operation Comparison of… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120137 | Victory Guidewire (32 Models) | 2012 | 0 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K120137 (Brivant, Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K060551.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Cruiser-18 Guidewires are intended for use in the peripheral vasculature
Contraindlications: The Cruiser-18 guide wire is not intended for use in the coronary or cerebral vasculature.
Patients judged not acceptable for percutaneous intervention (PPCI)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102211: Cruiser 18 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102211
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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