510(k) · Cleared
ClearedAcs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating.
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 Mar 25, 1999 as substantially equivalent to K981381 (Guidant Corp., 1998) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 1989. 3 of the 194 devices in its family, counting itself, have a Class I recall. 189 later devices descend from it.
- Decided
- Mar 25, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K890505 (1989). 4 ancestors in all. 189 later devices descend from it, 7 citing it directly. 3 of the 194 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 1 generation backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- This deviceK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- Descendant · cites it directly · 104 of its ownK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- Descendant · 2 generations on · 92 of its ownK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- Descendant · 2 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
- Descendant · 2 generations on · 75 of its ownK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 189 · See all- K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Jomed, Inc. · 2002 · cites it directly104descendants
- K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003 · 2 generations on92descendants
- K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd. · 2004 · 2 generations on79descendants
- K011986Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002 · cites it directly76descendants
- K021323Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002 · 2 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −1 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| 0 (this device) | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| +1 | 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 | — |
| +2 | K041531 | Asahi Ptca Guide Wire Confianza Pro | Asahi Intecc Co., Ltd. | 2004 | — |
| +1 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| +2 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K981381 | Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product Family…Summary page 1…™ 300 XT Guide Wire with HYDROCOAT™ Hydrophilic Coating Guide Wire Catheter Guide Wire (74DQX) ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K981381) ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K982083) Commander, Standard, Steerable Gui… | 1998 |
| * | K982083 | Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic CoatingSummary page 1…QX) ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K981381) ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K982083) Commander, Standard, Steerable Guide Wire; C.R. Bard, Inc. (K961271) 33 11. Device Description: The ACS HI-TO… | 1998 |
| * | K961271 | Usci Commander Series Guide WiresSummary page 1…ating (K981381) ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K982083) Commander, Standard, Steerable Guide Wire; C.R. Bard, Inc. (K961271) 33 11. Device Description: The ACS HI-TORQUE CROSS-IT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a ste… | 1996 |
What descends from it? (189)
See all 1897 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002… | 2002 | 104 |
| K011986 | Safe-Steer Guide Wire System | 2002 | 76 |
| K063819 | Asahi Ptca Guide Wire, Fielder FC | 2007 | 51 |
| K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | 2006 | 49 |
| K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371 | 2007 | 27 |
| K080901 | Lbi Embolectomy System | 2008 | 6 |
| K051062 | VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft)… | 2005 | 0 |
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 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K211738Rotarex Atherectomy SystemC.R. Bard, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K022762 (Jomed, Inc., 2002) has gone furthest, with 104 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 ACS HI-TORQUE CROSS-IT™ 100XT, 200X T and 300XT Guide Wire with HYDROCOAT™ Hydrophilic Coating family of guide wires’ intended use is:
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/K990639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990639
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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