510(k) · Cleared
Recalled · Class II · 2024Approach Hydro ST Wire Guide, Model HMW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQX Wire, Guide, Catheter
Cleared on Aug 7, 2009 after an 89-day review. The FDA summary names no predicate by number. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK091385 Approach Hydro ST Wire Guide, Model HMWCook, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK110009 Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK250203 SureAx-Guide™Sureax Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK130766 Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK123707 Alight 16 Superselective Microwire GuideCook, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K110009Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2011 · cites it directly2descendants
- K250203SureAx-Guide™Sureax Medical, LLC · 2025 · cites it directly0descendants
- K130766Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc. · 2013 · 2 generations on0descendants
- K123707Alight 16 Superselective Microwire GuideCook, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091385 | Approach Hydro ST Wire Guide, Model HMW | Cook, Inc. | 2009 | — |
| +1 | K110009 | Roadrunner Uniglide Hydrophilic Wire Guide | Cook, Inc. | 2011 | Class I |
| +1 | K250203 | SureAx-Guide™ | Sureax Medical, LLC | 2025 | — |
| +2 | K130766 | Roadrunner Uniglide Hydrophilic Wire Guide | Cook, Inc. | 2013 | Class I |
| +2 | K123707 | Alight 16 Superselective Microwire Guide | Cook, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2013 | 2 | 1 |
| 2025 | 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.
2 devices in this family have a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 8, 2024 | Class II | Z-0347-2025 | Labeling Change Control | Affected device lots have labels that state the incorrect expiration dates. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K110009 (Cook, Inc., 2011) has gone furthest, with 2 descendants of its own.
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?
Indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091385: Approach Hydro ST Wire Guide, Model HMW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091385
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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