510(k) · Cleared
ClearedPtca Steerable Hydrophilic 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 Jul 16, 2004 as substantially equivalent to K970376 (Lake Region Mfg., Inc., 1997) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 16, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970376 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 1 generation backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- This deviceK041624 Ptca Steerable Hydrophilic GuidewireLake Region Mfg., Inc. · 2004
- Descendant · cites it directly · 2 of its ownK052347 Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK060454 Titan GuidewireLake Region Mfg., Inc. · 2006
- Descendant · cites it directly · 0 of its ownK082922 Freeway and Railrunner GuidewiresLake Region Mfg., Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK073655 Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K052347Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2006 · cites it directly2descendants
- K060454Titan GuidewireLake Region Mfg., Inc. · 2006 · 2 generations on1descendant
- K082922Freeway and Railrunner GuidewiresLake Region Mfg., Inc. · 2008 · cites it directly0descendants
- K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −1 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| 0 (this device) | K041624 | Ptca Steerable Hydrophilic Guidewire | Lake Region Mfg., Inc. | 2004 | — |
| +1 | K052347 | Titan Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +2 | K060454 | Titan Guidewire | Lake Region Mfg., Inc. | 2006 | — |
| +1 | K082922 | Freeway and Railrunner Guidewires | Lake Region Mfg., Inc. | 2008 | — |
| +3 | K073655 | Pegasus Steerable (Ptca) Guidewire | Lake Region Mfg., Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K970376 | Ptca GuidewireSummary page 2…g Specifications The design specifications are the same for the proposed device as they are for the LRM predicate devices [reference 510(k)s K970376 and K01 1968]. The finished device with hydrophilic coating must meet the same basic design criteria… | 1997 |
| * | K011968 | Streerable Ptca GuidewireSummary page 2…The design specifications are the same for the proposed device as they are for the LRM predicate devices [reference 510(k)s K970376 and K01 1968]. The finished device with hydrophilic coating must meet the same basic design criteria and also meet the criteria… | 2001 |
| † | K991898 | Ultra-Select Guidewire, Hytek Guidewire | 1999 |
What descends from it? (4)
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 7 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K052347 (Lake Region Mfg., Inc., 2006) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K970376.
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/K041624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041624: Ptca Steerable Hydrophilic Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041624
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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