510(k) · Cleared
Recalled · 2008Galt Medical Guidewire
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 Jul 17, 2003 as substantially equivalent to K982559 (Galt Medical Corp., 1999) and 1 other predicate after a 27-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 17, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920884 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- 2 generations backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
- 1 generation backK021990 Galt Medical GuidewireGalt Medical Corp. · 2002 · Recalled
- This deviceK031916 Galt Medical GuidewireGalt Medical Corp. · 2003
- Descendant · cites it directly · 0 of its ownK033542 Easy Pass Hydrophilic Coated Vascular GuidewireGalt Medical Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K033542Easy Pass Hydrophilic Coated Vascular GuidewireGalt Medical Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| −2 | K982559 | Guidewire | Galt Medical Corp. | 1999 | 1 |
| −1 | K021990 | Galt Medical Guidewire | Galt Medical Corp. | 2002 | 1 |
| 0 (this device) | K031916 | Galt Medical Guidewire | Galt Medical Corp. | 2003 | — |
| +1 | K033542 | Easy Pass Hydrophilic Coated Vascular Guidewire | Galt Medical Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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 |
|---|---|---|---|
| * | K982559 | GuidewireSummary page 1…e, Guide, Catheter Classification Code: DQX (3) Substantial Equivalency: Galt Medical Corp. Sitefinder guidewires are substantially equivalent to guidewires from K982559 and K021990. (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with gu… | 1999 |
| * | K021990 | Galt Medical GuidewireSummary page 1…theter Classification Code: DQX (3) Substantial Equivalency: Galt Medical Corp. Sitefinder guidewires are substantially equivalent to guidewires from K982559 and K021990. (4) Device Description: The materials of construction stainless steel, nitinol, platinum are consistent with guidewires pre… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033542 | Easy Pass Hydrophilic Coated Vascular Guidewire | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2008 | Not classified | Z-1909-2008 | Mixed-up of materials/components | kit contains incorrect component |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K033542 (Galt Medical Corp., 2003) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K982559.
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 procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031916: Galt Medical Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031916
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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