510(k) · Cleared
ClearedPre-Formed 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 Jun 11, 2015 as substantially equivalent to K130798 (Lake Region Medical, Inc., 2013) after a 31-day review. Its family tree reaches back 2 generations to 1993. 10 later devices descend from it.
- Decided
- Jun 11, 2015
- Review
- 31 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930622 (1993). 10 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK930622 Amplatz GuidewiresMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 1 generation backK130798 Pre-Formed GuidewiresLake Region Medical, Inc. · 2013
- This deviceK151244 Pre-Formed GuidewireLake Region Medical · 2015
- Descendant · cites it directly · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK153397 S-Wire Guidewire SystemConcert Medical, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK251367 OptoMonitor 3Opsens, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K213854SavvyWireOpsens, Inc. · 2022 · cites it directly4descendants
- K241418OptoMonitor 3Opsens, Inc. · 2025 · 2 generations on1descendant
- K153397S-Wire Guidewire SystemConcert Medical, LLC · 2016 · cites it directly1descendant
- K251367OptoMonitor 3Opsens, Inc. · 2026 · 3 generations on0descendants
- K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930622 | Amplatz Guidewires | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −1 | K130798 | Pre-Formed Guidewires | Lake Region Medical, Inc. | 2013 | — |
| 0 (this device) | K151244 | Pre-Formed Guidewire | Lake Region Medical | 2015 | — |
| +1 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +2 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +1 | K153397 | S-Wire Guidewire System | Concert Medical, LLC | 2016 | — |
| +3 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | — |
| +2 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K130798 | Pre-Formed GuidewiresSummary page 4…ication 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) K130798 Pre-Formed Guidewires (Lake Region Medical) 2.6 DEVICE DESCRIPTION The 0.035” diameter, 260-300cm length g… | 2013 |
What descends from it? (10)
5 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 22 years and passes through 3 companies; a new generation was cleared every 20.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213854 (Opsens, Inc., 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K130798.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151244: Pre-Formed Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151244
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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