510(k) · Cleared
ClearedSafe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra Luminal Therapeutics, Inc. · DQX Wire, Guide, Catheter
Cleared on Jun 7, 2005 as substantially equivalent to K040037 (Intra Luminal Therapeutics, Inc., 2004) after a 56-day review. Its family tree reaches back 7 generations to 1989. 1 later device descends from it.
- Decided
- Jun 7, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890505 (1989). 11 ancestors in all, the oldest K881787 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 5 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 4 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 2 generations backK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- 1 generation backK040037 Modification to Safe-Cross Radio Frequency Total Occlusion Crossing…Intra Luminal Therapeutics, Inc. · 2004
- This deviceK050915 Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]Intra Luminal Therapeutics, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK073162 Safe-Cross (R) Radio Frequency Total Occlusion Crossing System…Kensey Nash Corporation · 2008
Most influential descendants
Showing 1 of 1 · See all- K073162Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio…Kensey Nash Corporation · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −6 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −5 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −4 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −2 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| −1 | K040037 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| 0 (this device) | K050915 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary] | Intra Luminal Therapeutics, Inc. | 2005 | — |
| +1 | K073162 | Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R)… | Kensey Nash Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K040037 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemSummary page 1…icate device is the Safe-Cross Radio Frequency Total Occlusion Crossing System, manufactured by IntraLuminal Therapeutics and cleared under Premarket Notification 510(k) K040037. DEVICE DESCRIPTION The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: * 175cm Wo… | 2004 |
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 |
|---|---|---|---|
| K073162 | Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio… | 2008 | 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 16 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K073162 (Kensey Nash Corporation, 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040037.
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 Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050915: Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050915
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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