510(k) · Cleared
ClearedAcuity Whisper View Guide Wires
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 Apr 8, 2011 as substantially equivalent to K061453 (Guidant Corp., 2006) and 1 other predicate after a 49-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Apr 8, 2011
- Review
- 49 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002206 (2000). 12 ancestors in all, the oldest K943192 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK002206 HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp. · 2000
- 5 generations backK013092 HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic…Guidant Corp. · 2001
- 4 generations backK020340 Modification to HI-Torque Whisper LS and MS Guide Wires with…Guidant Corp. · 2002
- 3 generations backK030019 Modification to HI-Torque Whisper GuidewireGuidant Corp. · 2003
- 2 generations backK061453 HI-Torque Whisper View Guide WireGuidant Corp. · 2006
- 1 generation backK090554 Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp · 2009
- This deviceK110479 Acuity Whisper View Guide WiresBoston Scientific Corp · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002206 | HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque… | Guidant Corp. | 2000 | — |
| −5 | K013092 | HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating | Guidant Corp. | 2001 | — |
| −4 | K020340 | Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat… | Guidant Corp. | 2002 | — |
| −3 | K030019 | Modification to HI-Torque Whisper Guidewire | Guidant Corp. | 2003 | — |
| −2 | K061453 | HI-Torque Whisper View Guide Wire | Guidant Corp. | 2006 | — |
| −1 | K090554 | Acuity Mailman and Strait-Trak Guidewire | Boston Scientific Corp | 2009 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K061453 | HI-Torque Whisper View Guide WireSummary page 1…Guide Wire Classification: Class 11, 21 CFR 870:1330 Product Code: DQX Predicate Devices: Guidant HI-TORQUE Whisper Viewt ' Guide Wire (K061453, cleared 06/22/2006) Boston Scientific ACUITYTMl MailmanT1 (Model 7081) and… | 2006 |
| * | K090554 | Acuity Mailman and Strait-Trak GuidewireSummary page 1…/22/2006) Boston Scientific ACUITYTMl MailmanT1 (Model 7081) and ACUITY Strait-Trakrl (Model 7082) Venous Guide wires (K(090554, cleared 07/2/2009) Device Description: The ACUITY Whisper View guide Wire family comprises three… | 2009 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 12 ancestors has a recall.
- 2 other devices also cite its predicate K061453.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 WHISPER VIEWTM Guide Wires with Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110479: Acuity Whisper View Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110479
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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