510(k) · Cleared
ClearedTitan Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Mfg., Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 24, 2006 as substantially equivalent to K052347 (Lake Region Mfg., Inc., 2006) after a 30-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Mar 24, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K941895 (1994). 20 ancestors in all, the oldest K913353 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
- 4 generations backK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- 3 generations backK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
- 2 generations backK042854 Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005
- 1 generation backK052347 Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006
- This deviceK060454 Titan GuidewireLake Region Mfg., Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073655 Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating | Scimed Life Systems, Inc. | 1994 | — |
| −4 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| −3 | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | 6 |
| −2 | K042854 | Stereotaxis Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| −1 | K052347 | Titan Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| 0 (this device) | K060454 | Titan Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +1 | K073655 | Pegasus Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K052347 | Titan Steerable (Ptca) GuidewireSummary page 3…stantial Equivalence Data: Lake Region believes these Titan 'M iterations are substantially equivalent to the Titan Soft Support predicate device cleared under 510(k) K052347. Performance specification changes to the TitanTM iterations are directly related to the varying tip flexibilities of the distal… | 2006 |
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 |
|---|---|---|---|
| K073655 | Pegasus Steerable (Ptca) Guidewire | 2008 | 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 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K073655 (Lake Region Mfg., Inc., 2008) has gone furthest, with 0 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?
For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060454 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060454: Titan Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060454
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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