510(k) · Cleared
ClearedHI-Torque Balance Trek Guide Wire
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 Apr 29, 1999 as substantially equivalent to K982083 (Guidant Corp., 1998) after a 23-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Apr 29, 1999
- Review
- 23 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982083 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK982083 Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat…Guidant Corp. · 1998
- This deviceK991152 HI-Torque Balance Trek Guide WireGuidant Corp. · 1999
- Descendant · cites it directly · 2 of its ownK152709 HI-Torque BalanceAbbott Vascular · 2015
- Descendant · 2 generations on · 0 of its ownK182553 Inno-PathwireSuzhou Innomed Medical Device Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK173052 Heraeus TMW GuidewireHeraeus Medical Components, LLC · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982083 | Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating | Guidant Corp. | 1998 | — |
| 0 (this device) | K991152 | HI-Torque Balance Trek Guide Wire | Guidant Corp. | 1999 | — |
| +1 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| +2 | K182553 | Inno-Pathwire | Suzhou Innomed Medical Device Co., Ltd. | 2019 | — |
| +2 | K173052 | Heraeus TMW Guidewire | Heraeus Medical Components, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K982083 | Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic CoatingSummary page 1…de Wires with HYDROCOAT™ Hydrophilic Coating Guide Wire Catheter Guide Wire (74DQX) ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating (K982083) 32 11. Device Description: The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a ste… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152709 | HI-Torque Balance | 2015 | 2 |
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?
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 intended use for the HI-TORQUE BALANCE TREK™ Guide Wires with HYDROCOAT™ Hydrophilic Coating is:
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.
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/K991152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991152: HI-Torque Balance Trek Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991152
Report an extraction error
Are you the manufacturer?
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