510(k) · Cleared
ClearedMedtronic Confida Brecker Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Core Valve, LLC · DQX Wire, Guide, Catheter
Cleared on May 3, 2018 as substantially equivalent to K150465 (Medtronic Core Valve, LLC, 2015) after a 17-day review. Its family tree reaches back 5 generations to 1992. 8 later devices descend from it.
- Decided
- May 3, 2018
- Review
- 17 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K920884 (1992). 9 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- 4 generations backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
- 3 generations backK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
- 2 generations backK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- 1 generation backK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- This deviceK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
- Descendant · cites it directly · 6 of its ownK192454 Wattson Temporary Pacing GuidewireVascular Solutions · 2020
- Descendant · 2 generations on · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK241418 OptoMonitor 3Opsens, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK251367 OptoMonitor 3Opsens, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK252674 Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192454Wattson Temporary Pacing GuidewireVascular Solutions · 2020 · cites it directly6descendants
- K213854SavvyWireOpsens, Inc. · 2022 · 2 generations on4descendants
- K241418OptoMonitor 3Opsens, Inc. · 2025 · 3 generations on1descendant
- K251367OptoMonitor 3Opsens, Inc. · 2026 · 4 generations on0descendants
- K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| −4 | K982559 | Guidewire | Galt Medical Corp. | 1999 | 1 |
| −3 | K042370 | Torayguide Guidewire | Toray Industries (America), Inc. | 2004 | — |
| −2 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| −1 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| 0 (this device) | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
| +1 | K192454 | Wattson Temporary Pacing Guidewire | Vascular Solutions | 2020 | — |
| +2 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
| +3 | K241418 | OptoMonitor 3 | Opsens, Inc. | 2025 | — |
| +4 | K251367 | OptoMonitor 3 | Opsens, Inc. | 2026 | — |
| +3 | K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K150465 | Medtronic Confida Brecker GuidewireSummary page 4…Guidewire Classification Name: Wire, Guide, Catheter Product Code: DQX Predicate Device(s): Medtronic ConfidaTM Brecker Guidewire (K150465 cleared August 03, 2015) Device Description: The Medtronic ConfidaTM Brecker G… | 2015 |
What descends from it? (8)
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 26 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K192454 (Vascular Solutions, 2020) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Medtronic Confida™ Brecker Guidewire is intended for use to introduce and position catheters during diagnostic and interventional procedures within the chambers of the heart, including transcatheter aortic valve implantation (TAVI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181001: Medtronic Confida Brecker Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181001
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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