510(k) · Cleared
ClearedHydraview 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 Sep 4, 2014 as substantially equivalent to K083094 (Brivant, Ltd., 2009) and 1 other predicate after a 59-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Sep 4, 2014
- Review
- 59 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K970376 (1997). 20 ancestors in all, the oldest K893626 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 7 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 6 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 5 generations backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- 4 generations backK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- 3 generations backK060551 Brivant GuidewireBrivant Limited · 2006
- 2 generations backK083094 Streamer Polymer GuidewireBrivant, Ltd. · 2009
- 1 generation backK103377 Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011
- This deviceK141831 Hydraview GuidewireBrivant Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −7 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −6 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −5 | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| −4 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| −3 | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| −2 | K083094 | Streamer Polymer Guidewire | Brivant, Ltd. | 2009 | — |
| −1 | K103377 | Charter Guidewire Model 45-281, 45-282, 45-283 | Brivant, Ltd. | 2011 | — |
| 0 (this device) | K141831 | Hydraview Guidewire | Brivant Limited | 2014 | — |
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 |
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 |
|---|---|---|---|
| * | K083094 | Streamer Polymer GuidewireSummary page 4…th Streamer Guidewire/ Brivant Limited K083094 7 July 2009 th… | 2009 |
| * | K103377 | Charter Guidewire Model 45-281, 45-282, 45-283Summary page 4…th Charter Guidewire/ Brivant Limited K103377 18 May 2011 Principle of Operation The HydraView guidewire is operated manually by a manual process Comparison of T… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 1 other device also cites its predicate K083094.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 HydraView Polymer Guidewires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141831: Hydraview Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141831
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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