510(k) · Cleared
ClearedHI-TORQUE Steelcore Bare Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular · DQX Wire, Guide, Catheter
Cleared on Apr 8, 2020 as substantially equivalent to K982876 (Guidant Corp., 1998) after a 77-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 8, 2020
- Review
- 77 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935997 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK935997 Platinum Plus GuidewireBoston Scientific Corp · 1994 · Recalled
- 2 generations backK963702 Acs HI-Torque Iron Man Guide WireAdvanced Cardiovascular Systems, Inc. · 1997
- 1 generation backK982876 HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281…Guidant Corp. · 1998
- This deviceK200144 HI-TORQUE Steelcore Bare Guide WireAbbott Vascular · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935997 | Platinum Plus Guidewire | Boston Scientific Corp | 1994 | 6 |
| −2 | K963702 | Acs HI-Torque Iron Man Guide Wire | Advanced Cardiovascular Systems, Inc. | 1997 | — |
| −1 | K982876 | HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282 | Guidant Corp. | 1998 | — |
| 0 (this device) | K200144 | HI-TORQUE Steelcore Bare Guide Wire | Abbott Vascular | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 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 |
|---|---|---|---|
| * | K982876 | HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282Summary page 4…lassification Catheter Guide Wire (21 CFR 870.1330; Product Code - Name DQX) 10. Predicate Device Name HT SteelcoreTM 18 Guide Wire (K982876, cleared on August 14, 1998) 11. Reference Devices HT Command®18 Guide Wire (K172073 c… | 1998 |
| † | K172073 | Hi-Torque Command 18 Guide Wire | 2017 |
| † | K193126 | HI-TORQUE InfilTrac Guide Wire Family | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K982876.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200144: HI-TORQUE Steelcore Bare Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200144
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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