510(k) · Cleared
ClearedCITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support Accessory, 0.023(126CM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ovalum, Ltd. · DQX Wire, Guide, Catheter
Cleared on Oct 12, 2007 as substantially equivalent to K041531 (Asahi Intecc Co., Ltd., 2004) and 2 other predicates after a 263-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it.
- Decided
- Oct 12, 2007
- Review
- 263 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K890505 (1989). 23 ancestors in all, the oldest K881787 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 5 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 4 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 3 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 2 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 1 generation backK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- This deviceK070212 CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM…Ovalum, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK171897 Approach CTO Microwire GuideCook Incorporated · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171897Approach CTO Microwire GuideCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −5 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −4 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −3 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −2 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −1 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| 0 (this device) | K070212 | CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop… | Ovalum, Ltd. | 2007 | — |
| +1 | K171897 | Approach CTO Microwire Guide | Cook Incorporated | 2017 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K041531 | Asahi Ptca Guide Wire Confianza ProSummary page 1…: The CiTopTM 0.014" Guidewire is substantially equivalent to the following predicate devices: * Asahi PTCA & PTA guidewire Confianza Pro - cleared under K041531 • Cordis STEER-IT Guidewire - cleared under K040592; * LuMend Frontrunner CTO Catheter and Accessories - K013284 Devic… | 2004 |
| * | K040592 | Cordis Steer-IT Deflecting Tip GuidewireSummary page 1…ivalent to the following predicate devices: * Asahi PTCA & PTA guidewire Confianza Pro - cleared under K041531 • Cordis STEER-IT Guidewire - cleared under K040592; * LuMend Frontrunner CTO Catheter and Accessories - K013284 Device Description: The CiTop Tm Guidewire has an outsid… | 2004 |
| * | K013284 | Lumend Frontrunner Cto Coronary CatheterSummary page 1…& PTA guidewire Confianza Pro - cleared under K041531 • Cordis STEER-IT Guidewire - cleared under K040592; * LuMend Frontrunner CTO Catheter and Accessories - K013284 Device Description: The CiTop Tm Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm.… | 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 |
|---|---|---|---|
| K171897 | Approach CTO Microwire Guide | 2017 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K171897 (Cook Incorporated, 2017) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K041531.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 CiTopTM Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesibns (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070212: CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support Accessory, 0.023(126CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070212
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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