510(k) · Cleared
ClearedTorayguide Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toray Industries (America), Inc. · DQX Wire, Guide, Catheter
Cleared on Dec 17, 2004 as substantially equivalent to K982559 (Galt Medical Corp., 1999) after a 108-day review. Its family tree reaches back 2 generations to 1992. 13 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 108 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920884 (1992). 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- 1 generation backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
- This deviceK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
- 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 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| −1 | K982559 | Guidewire | Galt Medical Corp. | 1999 | 1 |
| 0 (this device) | K042370 | Torayguide Guidewire | Toray Industries (America), Inc. | 2004 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 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? (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 |
|---|---|---|---|
| * | K982559 | GuidewireSummary page 1…: Catheter Guide Wire (74 DOX); 21 CFR, Part 870.1330 Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Guidewire (K982559) manufactured by Galt Medical Corporation, determined to be substantially equivalent to a legally marketed (preAmendment) device… | 1999 |
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)
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 12 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K132623 (Medtronic, 2013) has gone furthest, with 11 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?
The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042370: Torayguide Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042370
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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