510(k) · Cleared
ClearedSafe-Steer Guide Wire System
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 Apr 3, 2002 as substantially equivalent to K981381 (Guidant Corp., 1998) and 3 other predicates after a 281-day review. Its family tree reaches back 3 generations to 1989. 76 later devices descend from it.
- Decided
- Apr 3, 2002
- Review
- 281 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K890505 (1989). 7 ancestors in all, the oldest K881787 (1988). 76 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 2 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 1 generation backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- This deviceK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- Descendant · cites it directly · 75 of its ownK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- Descendant · 2 generations on · 40 of its ownK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- Descendant · 3 generations on · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- Descendant · 2 generations on · 36 of its ownK032031 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
- Descendant · 3 generations on · 31 of its ownK062868 The Crosser Catheter, Model CR1100 and System Electronics, Model…Flowcardia, Inc. · 2007
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K021323Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002 · cites it directly75descendants
- K031842Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003 · 2 generations on40descendants
- K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · 3 generations on36descendants
- K032031Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004 · 2 generations on36descendants
- K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc. · 2007 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −2 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −1 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| 0 (this device) | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| +1 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| +2 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| +3 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| +2 | K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2004 | — |
| +3 | K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 | Flowcardia, Inc. | 2007 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K981381 | Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product Family… Our OCR of the scanned summary read K881381, FDA’s number for Reagents for TSH Assay (Sclavo, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ACS Hi-Torque Cross-it Guide Wire”. | 1998 |
| * | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic…Summary page 1…rance Date of Preparation: March 28, 2002 Substantially Equivalent Legally Marketed Devices: Product Name 510(k) Numbers 1. ACS Hi-Torque Cross-it Guide Wire K881381 & K990639 2. ACS Hi-Torque Standard Guide Wire K881897 & K881787 Device Description: The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide… | 1999 |
| * | K881897 | Acs HI-Torque Floppy/Floppy II/Inter./Standard GWSummary page 1…stantially Equivalent Legally Marketed Devices: Product Name 510(k) Numbers 1. ACS Hi-Torque Cross-it Guide Wire K881381 & K990639 2. ACS Hi-Torque Standard Guide Wire K881897 & K881787 Device Description: The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire System is comprised of a sterile single… | 1988 |
| * | K881787 | Acs HI-Torque Standard & Intermedi. Guide WireSummary page 1…Equivalent Legally Marketed Devices: Product Name 510(k) Numbers 1. ACS Hi-Torque Cross-it Guide Wire K881381 & K990639 2. ACS Hi-Torque Standard Guide Wire K881897 & K881787 Device Description: The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire System is comprised of a sterile single-use guide… | 1988 |
What descends from it? (76)
See all 761 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021323 | Modification to Safe-Steer Guide Wire System | 2002 | 75 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K021323 (Intra Luminal Therapeutics, Inc., 2002) has gone furthest, with 75 descendants of its own.
- 1 other device also cites its predicate K981381.
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-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
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/K011986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011986: Safe-Steer Guide Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011986
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026