510(k) · Cleared
Recalled · 2010Back-UP Meier Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQX Wire, Guide, Catheter
Cleared on Aug 13, 2001 after a 55-day review. The FDA summary names its predicate without a number. 15 later devices descend from it. It has been recalled once.
- Decided
- Aug 13, 2001
- Review
- 55 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK011906 Back-UP Meier GuidewireBoston Scientific Corp · 2001
- Descendant · cites it directly · 14 of its ownK020283 Back-UP Meier Steerable GuidewireBoston Scientific Corp · 2002 · Recalled
- Descendant · 2 generations on · 13 of its ownK101339 Archer Super Stiff GuidewiresMedtronic, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 11 of its ownK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- Descendant · 4 generations on · 9 of its ownK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- Descendant · 5 generations on · 8 of its ownK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K020283Back-UP Meier Steerable GuidewireBoston Scientific Corp · 2002 · cites it directly14descendants
- K101339Archer Super Stiff GuidewiresMedtronic, Inc. · 2010 · 2 generations on13descendants
- K132623Medtronic Confida Brecker Curve GuidewireMedtronic · 2013 · 3 generations on11descendants
- K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015 · 4 generations on9descendants
- K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011906 | Back-UP Meier Guidewire | Boston Scientific Corp | 2001 | — |
| +1 | K020283 | Back-UP Meier Steerable Guidewire | Boston Scientific Corp | 2002 | 1 |
| +2 | K101339 | Archer Super Stiff Guidewires | Medtronic, Inc. | 2010 | 2 |
| +3 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| +4 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| +5 | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | — | Platinum Plus Guidewire Named without a submission number | |
| * | — | Amplatz Super Stiff Guidewire Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020283 | Back-UP Meier Steerable Guidewire | 2002 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2010 | Not classified | Z-1760-2010 | Nonconforming Material/Component | Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K020283 (Boston Scientific Corp, 2002) has gone furthest, with 14 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.
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 Back-Up Meier Guidewire is intended to facilitate placement of a catheter during diagnostic or interventional intravascular procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011906: Back-UP Meier Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011906
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026