510(k) · Cleared
Recalled · Class I · 2014Charlie Guidewire (Regular), Charlie Guidewire (Stiff)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidepath Medical, Inc. · DQX Wire, Guide, Catheter
Cleared on Dec 13, 2012 as substantially equivalent to K863138 (Terumo Medical Corp., 1986) and 2 other predicates after a 218-day review. Its family tree reaches back 7 generations to 1991. 1 of the 17 devices in its family, counting itself, has a Class I recall. It has been recalled 12 times, including 12 Class I recalls.
- Decided
- Dec 13, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 12 (12 Class I)
- Predicates
- 3
Its longest line of descent runs back 7 generations to K913353 (1991). 16 ancestors in all, the oldest K841926 (1985). No later device cites it as a predicate yet. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 6 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 5 generations backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- 4 generations backK013833 HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat…Guidant Corp. · 2002
- 3 generations backK072460 HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc. · 2008
- 2 generations backK091825 HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc. · 2009
- 1 generation backK101011 HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc. · 2010
- This deviceK121398 Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −6 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −5 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| −4 | K013833 | HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic… | Guidant Corp. | 2002 | — |
| −3 | K072460 | HI-Torque Balance Middleweight Universal II Guide Wire | Abbott Vascular, Inc. | 2008 | — |
| −2 | K091825 | HI-Torque Progress Guide Wire Family | Abbott Vascular, Inc. | 2009 | — |
| −1 | K101011 | HI-Torque Balance Middleweight Universal | Abbott Vascular, Inc. | 2010 | — |
| 0 (this device) | K121398 | Charlie Guidewire (Regular), Charlie Guidewire (Stiff) | Guidepath Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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.
1 device in this family has 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? (3)
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 |
|---|---|---|---|
| * | K863138 | Terumo Radifocus Guide Wire Our reading of the summary gave K863168, FDA’s number for Model 1101M & 1151M Urolab Micro Urodynamic Record (Life-Tech Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Terumo - Radifocus Guidewire”. | 1986 |
| * | K841926 | Hydroglide Spring Guide WiresSummary page 1…T CODE OQX - Catheter Guide Wire PREDICATE Terumo - Radifocus Guidewire (K863168) DEVICE Argon Medical - Guidewires (K841926) Abbott - Balance Middleweight Guidewire (K1i01011) DESCRIPTION OF THE DEVICE The Charlie Guidewi… | 1985 |
| * | K101011 | HI-Torque Balance Middleweight Universal | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2014 | Class I | Z-1823-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1821-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1818-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1820-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1817-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1815-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1813-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1816-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1819-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1814-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1822-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
| May 28, 2014 | Class I | Z-1812-2014 | Device Design | Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. |
The 5 latest of 12 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 21 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 16 ancestors has a recall.
- 11 other devices also cite its predicate K863138.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
To facilitate the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventionial procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121398: Charlie Guidewire (Regular), Charlie Guidewire (Stiff).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121398
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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