510(k) · Cleared
ClearedAcuity Mailman and Strait-Trak Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQX Wire, Guide, Catheter
Cleared on Jul 2, 2009 as substantially equivalent to K964551 (Scimed Life Systems, Inc., 1997) and 1 other predicate after a 122-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jul 2, 2009
- Review
- 122 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K002206 (2000). 11 ancestors in all, the oldest K943192 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
- 4 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
- 3 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
- 2 generations backK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
- 1 generation backK061453 HI-Torque Whisper View Guide WireGuidant Corp. · 2006
- This deviceK090554 Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009
- Descendant · cites it directly · 0 of its ownK110479 Acuity Whisper View Guide WiresBoston Scientific Corp · 2011
Most influential descendants
Showing 1 of 1 · See all- K110479Acuity Whisper View Guide WiresBoston Scientific Corp · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002206 | HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque… | Guidant Corp. | 2000 | — |
| −4 | K013092 | HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating | Guidant Corp. | 2001 | — |
| −3 | K020340 | Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat… | Guidant Corp. | 2002 | — |
| −2 | K030019 | Modification to HI-Torque Whisper Guidewire | Guidant Corp. | 2003 | — |
| −1 | K061453 | HI-Torque Whisper View Guide Wire | Guidant Corp. | 2006 | — |
| 0 (this device) | K090554 | Acuity Mailman and Strait-Trak Guidewire | Boston Scientific Corp | 2009 | — |
| +1 | K110479 | Acuity Whisper View Guide Wires | Boston Scientific Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…Summary page 1…e DQX Classification of Catheter Guidewire Device Class II, 21 CFR Part 870.1330 Predicate Boston Scientific K964551 May 21, 1997 Devices ChoICE Extra Support and Mailman… | 1997 |
| * | K061453 | HI-Torque Whisper View Guide WireSummary page 1…E Extra Support and Mailman PTCA Guidewires Guidant K061453 June 22, 2006 HI-TORQUE Whisper View Guidewir… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110479 | Acuity Whisper View Guide Wires | 2011 | 0 |
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 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K110479 (Boston Scientific Corp, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K964551.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090554 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090554: Acuity Mailman and Strait-Trak Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090554
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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