510(k) · Cleared
ClearedHeraeus TMW Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Medical Components, LLC · DQX Wire, Guide, Catheter
Cleared on Oct 20, 2017 as substantially equivalent to K152709 (Abbott Vascular, 2015) after a 22-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Oct 20, 2017
- Review
- 22 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913353 (1991). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 7 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 6 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 5 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 4 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- 3 generations backK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009
- 2 generations backK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010
- 1 generation backK152709 HI-Torque BalanceAbbott Vascular · 2015
- This deviceK173052 Heraeus TMW GuidewireHeraeus Medical Components, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −7 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −6 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −5 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −4 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| −3 | K091825 | HI-Torque Progress Guide Wire Family | Abbott Vascular, Inc. | 2009 | — |
| −2 | K101011 | HI-Torque Balance Middleweight Universal | Abbott Vascular, Inc. | 2010 | — |
| −1 | K152709 | HI-Torque Balance | Abbott Vascular | 2015 | — |
| 0 (this device) | K173052 | Heraeus TMW Guidewire | Heraeus Medical Components, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K152709 | HI-Torque BalanceSummary page 4…3 cm radiopaque distal tip. Predicate Device: The subject device is substantially equivalent to the Hi-Torque Balance Middleweight Guidewire (K152709, 10/21/2015) manufactured by Abbott Vascular. Principle of The Heraeus TMW Guidewire… | 2015 |
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 5 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K152709.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173052: Heraeus TMW Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173052
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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