510(k) · Cleared
ClearedPre-Formed Guidewires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Medical, Inc. · DQX Wire, Guide, Catheter
Cleared on Aug 23, 2013 as substantially equivalent to K930622 (Meadox Medicals, Div. Boston Scientific Corp., 1993) after a 154-day review. Its family tree reaches back 1 generation to 1993. 11 later devices descend from it.
- Decided
- Aug 23, 2013
- Review
- 154 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930622 (1993). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930622 Amplatz GuidewiresMeadox Medicals, Div. Boston Scientific Corp. · 1993
- This deviceK130798 Pre-Formed GuidewiresLake Region Medical, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK151244 Pre-Formed GuidewireLake Region Medical · 2015
- Descendant · 2 generations on · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · 3 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 · 4 generations on · 0 of its ownK251367 OptoMonitor 3Opsens, Inc. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151244Pre-Formed GuidewireLake Region Medical · 2015 · cites it directly10descendants
- K213854SavvyWireOpsens, Inc. · 2022 · 2 generations on4descendants
- K241418OptoMonitor 3Opsens, Inc. · 2025 · 3 generations on1descendant
- K153397S-Wire Guidewire SystemConcert Medical, LLC · 2016 · cites it directly1descendant
- K251367OptoMonitor 3Opsens, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930622 | Amplatz Guidewires | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| 0 (this device) | K130798 | Pre-Formed Guidewires | Lake Region Medical, Inc. | 2013 | — |
| +1 | K151244 | Pre-Formed Guidewire | Lake Region Medical | 2015 | — |
| +2 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +3 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +1 | K153397 | S-Wire Guidewire System | Concert Medical, LLC | 2016 | — |
| +4 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K930622 | Amplatz GuidewiresSummary page 1…441 Pre-Formned Guidewire CATHETER GUIDE WIRE (DQX) This type of Guidewire was originaliy listed as a Class 11 device by the Cardiovascular (DQX) review panel. K930622 Boston Scientific Amplatz SuperStiff Guidewire The 0.035" diameter, 260cm-300cm length… | 1993 |
What descends from it? (11)
See all 112 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?
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 within transcatheter
aortic valve procedures.
This guidewire is not intended for use in the cerebrovasculature or coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130798: Pre-Formed Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130798
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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