510(k) · Cleared
ClearedAcs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product Family Models 1003211H,1003212HJ,1003213H,1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · DQX Wire, Guide, Catheter
Cleared on Jul 15, 1998 after a 90-day review. The FDA summary names its predicate without a number. 3 of the 191 devices in its family, counting itself, have a Class I recall. 190 later devices descend from it.
- Decided
- Jul 15, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 0
190 later devices descend from it, 2 citing it directly. 3 of the 191 devices in this family, counting this one, have a Class I recall.
- This deviceK981381 Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 1998
- Descendant · cites it directly · 189 of its ownK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- Descendant · 2 generations on · 104 of its ownK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- Descendant · 3 generations on · 92 of its ownK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- Descendant · 3 generations on · 79 of its ownK041531 Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004
- Descendant · cites it directly · 76 of its ownK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
Showing 5 of 190 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 190 · See all- K990639Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic…Guidant Corp. · 1999 · cites it directly189descendants
- K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Jomed, Inc. · 2002 · 2 generations on104descendants
- K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003 · 3 generations on92descendants
- K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004 · 3 generations on79descendants
- K011986Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002 · cites it directly76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981381 | Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product… | Guidant Corp. | 1998 | — |
| +1 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| +2 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| +3 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| +3 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| +1 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 11 | 0 |
| 2018 | 10 | 1 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 1 |
| 2022 | 14 | 0 |
| 2023 | 12 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 1 |
| 2026 | 4 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating Named without a submission number |
What descends from it? (190)
See all 1902 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K172315Straub Endovascular SystemStraub Medical AG · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K990639 (Guidant Corp., 1999) has gone furthest, with 189 descendants of its own.
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?
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
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/K981381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981381: Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product Family Models 1003211H,1003212HJ,1003213H,1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981381
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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