510(k) · Cleared
ClearedMandrel Guidewires or M-Wires
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 26, 2008 as substantially equivalent to K011084 (Lake Region Mfg., Inc., 2001) after a 35-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011084 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011084 Mandrel Guidewire AssemblyLake Region Mfg., Inc. · 2001
- This deviceK080144 Mandrel Guidewires or M-WiresLake Region Mfg., Inc. · 2008
- Descendant · cites it directly · 2 of its ownK140485 Mandrel GuidewireLake Region Medical · 2014
- Descendant · 2 generations on · 1 of its ownK142393 Predicate Iii GuidewireLake Region Medical · 2014
- Descendant · 3 generations on · 0 of its ownK241784 Arrow® Nitinol WireTeleflex Medical · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011084 | Mandrel Guidewire Assembly | Lake Region Mfg., Inc. | 2001 | — |
| 0 (this device) | K080144 | Mandrel Guidewires or M-Wires | Lake Region Mfg., Inc. | 2008 | — |
| +1 | K140485 | Mandrel Guidewire | Lake Region Medical | 2014 | — |
| +2 | K142393 | Predicate Iii Guidewire | Lake Region Medical | 2014 | — |
| +3 | K241784 | Arrow® Nitinol Wire | Teleflex Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K011084 | Mandrel Guidewire AssemblySummary page 2…e and has been found to be acceptable. Lake Region believes the Mandrel Guidewire iterations are substantially equivalent to the predicate devices cleared under 510(k) K011084. All non-clinical test results support the claim of substantial equivalence to the predicate devices. Mandrel Guidewires are in… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140485 | Mandrel Guidewire | 2014 | 2 |
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?
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
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/K080144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080144: Mandrel Guidewires or M-Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080144
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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