510(k) · Cleared
ClearedTitan Steerable (Ptca) 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 Feb 17, 2006 as substantially equivalent to K041624 (Lake Region Mfg., Inc., 2004) and 1 other predicate after a 172-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 17, 2006
- Review
- 172 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K941895 (1994). 19 ancestors in all, the oldest K913353 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
- 3 generations backK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- 2 generations backK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
- 1 generation backK042854 Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005
- This deviceK052347 Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006
- Descendant · cites it directly · 1 of its ownK060454 Titan GuidewireLake Region Mfg., Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK073655 Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008
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 |
|---|---|---|---|---|---|
| −4 | K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating | Scimed Life Systems, Inc. | 1994 | — |
| −3 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| −2 | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | 6 |
| −1 | K042854 | Stereotaxis Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| 0 (this device) | K052347 | Titan Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +1 | K060454 | Titan Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +2 | 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 |
|---|---|---|
| 2006 | 1 | 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 |
|---|---|---|---|
| * | K041624 | Ptca Steerable Hydrophilic GuidewireSummary page 3…e. Substantial Equivalence Data: Lake Region believes this device is substantially equivalent to the predicate device. The Lake Region device, cleared under 510(k) K041624, is the primary predicate; while the Stereotaxis device, cleared under K042854 is the secondary predicate to show that material a… | 2004 |
| * | K042854 | Stereotaxis Endovascular Guide WireSummary page 3…tially equivalent to the predicate device. The Lake Region device, cleared under 510(k) K041624, is the primary predicate; while the Stereotaxis device, cleared under K042854 is the secondary predicate to show that material additions (gold cup/spacer and magnet at the distal tip) are used in a previousl… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060454 | Titan Guidewire | 2006 | 1 |
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 2.8 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K060454 (Lake Region Mfg., Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K041624.
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/K052347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052347: Titan Steerable (Ptca) Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052347
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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