510(k) · Cleared
ClearedSafe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra Luminal Therapeutics, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Jun 8, 2005 as substantially equivalent to K040037 (Intra Luminal Therapeutics, Inc., 2004) after a 57-day review. Its family tree reaches back 7 generations to 1989. 16 later devices descend from it.
- Decided
- Jun 8, 2005
- Review
- 57 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890505 (1989). 11 ancestors in all, the oldest K881787 (1988). 16 later devices descend from it, 2 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 deviceK050916 Safe-Cross Radio Frequency Total Occlusion Crossing System…Intra Luminal Therapeutics, Inc. · 2005
- Descendant · cites it directly · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK152275 Pantheris SystemAvinger, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K122380Ocelot SystemAvinger, Inc. · 2012 · cites it directly14descendants
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 2 generations on12descendants
- K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · 2 generations on7descendants
- K152275Pantheris SystemAvinger, Inc. · 2015 · 3 generations on6descendants
- K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. · 2016 · 4 generations on5descendants
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) | K050916 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] | Intra Luminal Therapeutics, Inc. | 2005 | — |
| +1 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| +2 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| +2 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
| +3 | K152275 | Pantheris System | Avinger, Inc. | 2015 | — |
| +4 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016 | — |
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 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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: e 0.014” Safe-Cr… | 2004 |
What descends from it? (16)
See all 162 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 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, K122380 (Avinger, Inc., 2012) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K040037.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
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 peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050916: Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050916
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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