510(k) · Cleared
Recalled · Class II · 2025Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galt Medical Corp. · DQX Wire, Guide, Catheter
Cleared on Feb 1, 1999 as substantially equivalent to K920884 (Acme-Monaco Corp., 1992) after a 193-day review. Its family tree reaches back 1 generation to 1992. 25 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 1999
- Review
- 193 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920884 (1992). 25 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- This deviceK982559 GuidewireGalt Medical Corp. · 1999
- Descendant · cites it directly · 13 of its ownK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
- Descendant · 2 generations on · 11 of its ownK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- Descendant · 3 generations on · 9 of its ownK150465 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015
- Descendant · 4 generations on · 8 of its ownK181001 Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018
- Descendant · cites it directly · 8 of its ownK021990 Galt Medical GuidewireGalt Medical Corp. · 2002 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K042370Torayguide GuidewireToray Industries (America), Inc. · 2004 · cites it directly13descendants
- K132623Medtronic Confida Brecker Curve GuidewireMedtronic · 2013 · 2 generations on11descendants
- K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2015 · 3 generations on9descendants
- K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC · 2018 · 4 generations on8descendants
- K021990Galt Medical GuidewireGalt Medical Corp. · 2002 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| 0 (this device) | K982559 | Guidewire | Galt Medical Corp. | 1999 | — |
| +1 | K042370 | Torayguide Guidewire | Toray Industries (America), Inc. | 2004 | — |
| +2 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| +3 | K150465 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2015 | — |
| +4 | K181001 | Medtronic Confida Brecker Guidewire | Medtronic Core Valve, LLC | 2018 | — |
| +1 | K021990 | Galt Medical Guidewire | Galt Medical Corp. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K920884 | Guidewires, Various TypesSummary page 1…fication Code: 74DQX (3) Substantial Equivalency: Galt Medical Corp.’s guidewires are substantially equivalent to guidewires from: Argon Medical Cordis Cook Acme 510(k) K920884 (4) Device Description and Intended Use: The material of construction is stainless steel which is consistent with guidewires pre… | 1992 |
| * | — | Argon Medical guidewires Named without a submission number | |
| * | — | Cordis guidewires Named without a submission number | |
| * | — | Cook guidewires Named without a submission number |
What descends from it? (25)
See all 255 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 27, 2025 | Class II | Z-1734-2025 | Process control | Due to a potential open seal in the sterile barrier packaging. |
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.
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?
These guidewires are intended for use in percutaneous procedure to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
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/K982559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982559: Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982559
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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