510(k) · Cleared
Recalled · Class II · 2022Double Flexible Tipped Wire Guides
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DQX Wire, Guide, Catheter
Cleared on Jun 14, 2018 as substantially equivalent to K171912 (Cook Incorporated, 2018) after a 23-day review. Its family tree reaches back 3 generations to 1977. It has been recalled once.
- Decided
- Jun 14, 2018
- Review
- 23 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K770977 (1977). No later device cites it as a predicate yet.
- Root · 3 generations backK770977 Cardiovascular Spring GuidesLake Region Mfg., Inc. · 1977 · Recalled
- 2 generations backK150802 Heavy Double Flexible Tipped Wire GuideCook Incorporated · 2015
- 1 generation backK171912 Double Flexible Tip Wire GuidesCook Incorporated · 2018 · Recalled
- This deviceK181351 Double Flexible Tipped Wire GuidesCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| −2 | K150802 | Heavy Double Flexible Tipped Wire Guide | Cook Incorporated | 2015 | — |
| −1 | K171912 | Double Flexible Tip Wire Guides | Cook Incorporated | 2018 | 2 |
| 0 (this device) | K181351 | Double Flexible Tipped Wire Guides | Cook Incorporated | 2018 | — |
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 |
|---|---|---|---|
| * | K171912 | Double Flexible Tip Wire GuidesSummary page 4…icate Device: The predicate device, manufactured by Cook Incorporated, is the Double Flexible Tipped Wire Guides, cleared for commercial distribution under 510(k) number K171912, on March 19, 2018. Reference Device: The reference device, manufactured by Cook Incorporated, is the Fixed Core Wire Guides cle… | 2018 |
| † | K171764 | Fixed Core Wire Guides | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2022 | Class II | Z-1831-2022 | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Double Flexible Tipped Wire Guides are used to facilitate the placement of devices during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181351: Double Flexible Tipped Wire Guides.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181351
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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