510(k) · Cleared
ClearedCharter Guidewire Model 45-281, 45-282, 45-283
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 May 18, 2011 as substantially equivalent to K060551 (Brivant Limited, 2006) and 2 other predicates after a 182-day review. Its family tree reaches back 7 generations to 1997. 2 later devices descend from it.
- Decided
- May 18, 2011
- Review
- 182 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K970376 (1997). 19 ancestors in all, the oldest K893626 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 6 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 5 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 4 generations backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- 3 generations backK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- 2 generations backK060551 Brivant GuidewireBrivant Limited · 2006
- 1 generation backK083094 Streamer Polymer GuidewireBrivant, Ltd. · 2009
- This deviceK103377 Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK141831 Hydraview GuidewireBrivant Limited · 2014
- Descendant · cites it directly · 0 of its ownK122856 Charter GuidewireBrivant, Ltd. · 2012
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 |
|---|---|---|---|---|---|
| −7 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −6 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −5 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −4 | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| −3 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| −2 | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| −1 | K083094 | Streamer Polymer Guidewire | Brivant, Ltd. | 2009 | — |
| 0 (this device) | K103377 | Charter Guidewire Model 45-281, 45-282, 45-283 | Brivant, Ltd. | 2011 | — |
| +1 | K141831 | Hydraview Guidewire | Brivant Limited | 2014 | — |
| +1 | K122856 | Charter Guidewire | 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 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K060551 | Brivant GuidewireSummary page 1…te Devices Manufacturer 510k Date BrivanttLtd, Brivant Guidewire K060551 07 Jun 2006 Brivant Ltd, Streamer Guidewire K083094 07 July 2009… | 2006 |
| * | K083094 | Streamer Polymer GuidewireSummary page 1…BrivanttLtd, Brivant Guidewire K060551 07 Jun 2006 Brivant Ltd, Streamer Guidewire K083094 07 July 2009 Brivant Ltd, Courier Guidewire IK073082 09 Jan 2008 === Pag… | 2009 |
| * | K073082 | CPS Courier GuidewireSummary page 1…Brivant Ltd, Streamer Guidewire K083094 07 July 2009 Brivant Ltd, Courier Guidewire IK073082 09 Jan 2008 Lak Regin Navilyst Charter 510(k)… | 2008 |
What descends from it? (2)
2 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 14 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K141831 (Brivant Limited, 2014) 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. 2011, 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?
Charter Guidewires are intended for use in the coronary and peripheral vasculature.
Contraindications: The Charter Guidewire is not intended for use in the cerebral vasculature.
Patients judged not acceptable for percutaneous intervention (PCI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103377: Charter Guidewire Model 45-281, 45-282, 45-283.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103377
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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