510(k) · Cleared
ClearedMandrel Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Medical · DQX Wire, Guide, Catheter
Cleared on Mar 27, 2014 as substantially equivalent to K011084 (Lake Region Mfg., Inc., 2001) and 2 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1977. 2 later devices descend from it.
- Decided
- Mar 27, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K770977 (1977). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
- 1 generation backK033758 Hydrophilic GuidewireLake Region Mfg., Inc. · 2003
- This deviceK140485 Mandrel GuidewireLake Region Medical · 2014
- Descendant · cites it directly · 1 of its ownK142393 Predicate Iii GuidewireLake Region Medical · 2014
- Descendant · 2 generations on · 0 of its ownK241784 Arrow® Nitinol WireTeleflex Medical · 2024
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 |
|---|---|---|---|---|---|
| −2 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| −1 | K033758 | Hydrophilic Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| 0 (this device) | K140485 | Mandrel Guidewire | Lake Region Medical | 2014 | — |
| +1 | K142393 | Predicate Iii Guidewire | Lake Region Medical | 2014 | — |
| +2 | K241784 | Arrow® Nitinol Wire | Teleflex Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (3)
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 1…sification name and product code is Catheter Guidewire (DQX) and is considered a Class II device per 21 CFR Part 870.1330. 2.5 IDENTIFICATION OF PREDICATE DEVICE(s) K011084 Mandrel Guidewires (Lake Region Medical) K033758 Mandrel Guidewires (Lake Region Medical) K080144… | 2001 |
| * | K033758 | Hydrophilic GuidewireSummary page 1…and is considered a Class II device per 21 CFR Part 870.1330. 2.5 IDENTIFICATION OF PREDICATE DEVICE(s) K011084 Mandrel Guidewires (Lake Region Medical) K033758 Mandrel Guidewires (Lake Region Medical) K080144 Mandrel Guidewires (Lake Region Medical) 2.6 DEVICE… | 2003 |
| * | K080144 | Mandrel Guidewires or M-WiresSummary page 1…2.5 IDENTIFICATION OF PREDICATE DEVICE(s) K011084 Mandrel Guidewires (Lake Region Medical) K033758 Mandrel Guidewires (Lake Region Medical) K080144 Mandrel Guidewires (Lake Region Medical) 2.6 DEVICE DESCRIPTION The Mandrel wire family is made of a coated (PTF… | 2008 |
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 |
|---|---|---|---|
| K142393 | Predicate Iii Guidewire | 2014 | 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 37 years and passes through 2 companies; a new generation was cleared every 26.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K142393 (Lake Region Medical, 2014) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K011084.
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?
Mandrel guidewires are intended 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/K140485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140485: Mandrel Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140485
Report an extraction error
Are you the manufacturer?
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