510(k) · Cleared
Recalled · Class II · 2013Archer Super Stiff Guidewires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DQX Wire, Guide, Catheter
Cleared on Aug 31, 2010 as substantially equivalent to K061670 (William Cook Europe Aps, 2007) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 31, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011906 (2001). 3 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011906 Back-UP Meier GuidewireBoston Scientific Corp · 2001 · Recalled
- 1 generation backK020283 Back-UP Meier Steerable GuidewireBoston Scientific Corp · 2002 · Recalled
- This deviceK101339 Archer Super Stiff GuidewiresMedtronic, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- Descendant · 2 generations on · 9 of its ownK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- Descendant · 3 generations on · 8 of its ownK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
- Descendant · 4 generations on · 6 of its ownK192454 Wattson Temporary Pacing GuidewireVascular Solutions · 2020
- Descendant · 5 generations on · 4 of its ownK213854 SavvyWireOpsens, Inc. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K132623Medtronic Confida Brecker Curve GuidewireMedtronic · 2013 · cites it directly11descendants
- K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015 · 2 generations on9descendants
- K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018 · 3 generations on8descendants
- K192454Wattson Temporary Pacing GuidewireVascular Solutions · 2020 · 4 generations on6descendants
- K213854SavvyWireOpsens, Inc. · 2022 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011906 | Back-UP Meier Guidewire | Boston Scientific Corp | 2001 | 1 |
| −1 | K020283 | Back-UP Meier Steerable Guidewire | Boston Scientific Corp | 2002 | 1 |
| 0 (this device) | K101339 | Archer Super Stiff Guidewires | Medtronic, Inc. | 2010 | — |
| +1 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| +2 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| +3 | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
| +4 | K192454 | Wattson Temporary Pacing Guidewire | Vascular Solutions | 2020 | — |
| +5 | K213854 | SavvyWire | Opsens, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K061670 | Lunderquist Wire Guide; DC Wire GuideSummary page 2…G61iii~ire Wire Guides Chid'ewlire- Diameter (!tilk):kj (1K061670) (K020283)' Length 200 cm 260 cm 185… | 2007 |
| * | K020283 | Back-UP Meier Steerable GuidewireSummary page 1…Lunderquist Wire Guide (K06l670) Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283) Device Description: The Medtronic Archer Super Stiff Guidewire is a PTFE c… | 2002 |
What descends from it? (13)
See all 132 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2013 | Class II | Z-1017-2013 | Mixed-up of materials/components | Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use. |
| Mar 13, 2013 | Class II | Z-1019-2013 | Component change control | Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K132623 (Medtronic, 2013) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K061670.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101339: Archer Super Stiff Guidewires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101339
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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