510(k) · Cleared
ClearedCROSSLEAD Standard 035 and CROSSLEAD Stiff 035
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Filmecc Co., Ltd. · DQX Wire, Guide, Catheter
Cleared on Sep 3, 2026 as substantially equivalent to K213315 (Asahi Intecc Co., Ltd., 2022) and 2 other predicates after a 139-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Sep 3, 2026
- Review
- 139 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K863138 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK863138 Terumo Radifocus Guide WireTerumo Medical Corp. · 1986
- 2 generations backK063372 Radifocus Glidewire AdvantageTerumo Medical Corp. · 2007
- 1 generation backK213315 CROSSLEAD Peripheral Guide WireAsahi Intecc Co., Ltd. · 2022
- This deviceK261281 CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863138 | Terumo Radifocus Guide Wire | Terumo Medical Corp. | 1986 | — |
| −2 | K063372 | Radifocus Glidewire Advantage | Terumo Medical Corp. | 2007 | — |
| −1 | K213315 | CROSSLEAD Peripheral Guide Wire | Asahi Intecc Co., Ltd. | 2022 | — |
| 0 (this device) | K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K213315 | CROSSLEAD Peripheral Guide WireSummary page 5…Classification Name: Catheter, Guide, Wire Product Code: DQX – Catheter Guide Wire Predicate Device: CROSSLEAD Peripheral Guide Wire (K213315) Terumo Radifocus Guidewire (K863138/K152740) Reference Devices: VAS… | 2022 |
| * | K863138 | Terumo Radifocus Guide WireSummary page 5…DQX – Catheter Guide Wire Predicate Device: CROSSLEAD Peripheral Guide Wire (K213315) Terumo Radifocus Guidewire (K863138/K152740) Reference Devices: VASSALLO GT Crossing 14 (K232574) Indication For Use/Intended Use:… | 1986 |
| * | K152740 | Radifocus GlidewireSummary page 5…DQX – Catheter Guide Wire Predicate Device: CROSSLEAD Peripheral Guide Wire (K213315) Terumo Radifocus Guidewire (K863138/K152740) Reference Devices: VASSALLO GT Crossing 14 (K232574) Indication For Use/Intended Use: Th… | 2015 |
| † | K232574 | VASSALLO GT Crossing14 | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is intended for peripheral vascular use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261281: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261281
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026