510(k) · Cleared
ClearedEnroute 0.014'' Transcarotid Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lake Region Medical · DQX Wire, Guide, Catheter
Cleared on Mar 19, 2026 as substantially equivalent to K160643 (Lake Region Medical, 2016) after a 114-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Mar 19, 2026
- Review
- 114 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970376 (1997). 14 ancestors in all, the oldest K893626 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 6 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 5 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 4 generations backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- 3 generations backK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- 2 generations backK060551 Brivant GuidewireBrivant Limited · 2006
- 1 generation backK160643 ENROUTE 0.014 GuidewireLake Region Medical · 2016
- This deviceK253746 Enroute 0.014'' Transcarotid GuidewireLake Region Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −6 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −5 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −4 | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| −3 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| −2 | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| −1 | K160643 | ENROUTE 0.014 Guidewire | Lake Region Medical | 2016 | — |
| 0 (this device) | K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 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 |
|---|---|---|---|
| * | K160643 | ENROUTE 0.014 GuidewireSummary page 5…Enroute 0.014’’ Guidewire Manufacturer: Lake Region Medical 510(k) Number: K160643 Regulatory Class: Class II (21 CFR §870.1330) Product Code:… | 2016 |
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 29 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 14 ancestors has 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. 2026, 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 Enroute Transcarotid 0.014'' Guidewire is intended for use in the peripheral vasculature, inclusive of the carotid artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253746: Enroute 0.014'' Transcarotid Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253746
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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