510(k) · Cleared
Recalled · Class II · 2022Fixed Core 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 Mar 9, 2018 as substantially equivalent to K133230 (Merit Medical Systems, Inc., 2013) after a 268-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Mar 9, 2018
- Review
- 268 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002289 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002289 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2000
- 1 generation backK133230 Inqwire Diagnostic Guide WireMerit Medical Systems, Inc. · 2013
- This deviceK171764 Fixed Core Wire GuidesCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK253667 Accoat Guide WireSp Medical A/S · 2026
Most influential descendants
Showing 1 of 1 · See all- K253667Accoat Guide WireSp Medical A/S · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002289 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | 2000 | — |
| −1 | K133230 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | 2013 | — |
| 0 (this device) | K171764 | Fixed Core Wire Guides | Cook Incorporated | 2018 | — |
| +1 | K253667 | Accoat Guide Wire | Sp Medical A/S | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K133230 | Inqwire Diagnostic Guide WireSummary page 4…guide wire Regulation: 21 CFR §870.1330 Product Code: DQX Predicate Device: The InQwire® Merit Medical Guide Wire (Merit Medical Inc., K133230) is a fixed core wire guide intended to facilitate placement of devices during diagnostic and interventional procedures. Referen… | 2013 |
| † | K140485 | Mandrel Guidewire | 2014 |
| † | K120119 | Sunmed Guide Wire | 2012 |
| † | K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM… | 2013 |
| † | K142393 | Predicate Iii Guidewire | 2014 |
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 |
|---|---|---|---|
| K253667 | Accoat Guide Wire | 2026 | 0 |
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-1832-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1828-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1825-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1833-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1842-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1845-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1827-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1834-2022 | 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. |
| Aug 16, 2022 | Class II | Z-1836-2022 | 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. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253667 (Sp Medical A/S, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133230.
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?
Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171764: Fixed Core 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/K171764
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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