510(k) · Cleared
ClearedENROUTE 0.014 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 Oct 18, 2016 as substantially equivalent to K060551 (Brivant Limited, 2006) and 1 other predicate after a 225-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Oct 18, 2016
- Review
- 225 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970376 (1997). 13 ancestors in all, the oldest K893626 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 5 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 4 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 3 generations backK040345 Modification to Nitrex Nitinol GuidewireEv3, Inc. · 2004
- 2 generations backK050756 Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L. · 2005
- 1 generation backK060551 Brivant GuidewireBrivant Limited · 2006
- This deviceK160643 ENROUTE 0.014 GuidewireLake Region Medical · 2016
- Descendant · cites it directly · 0 of its ownK253746 Enroute 0.014'' Transcarotid GuidewireLake Region Medical · 2026
Most influential descendants
Showing 1 of 1 · See all- K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −5 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −4 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −3 | K040345 | Modification to Nitrex Nitinol Guidewire | Ev3, Inc. | 2004 | — |
| −2 | K050756 | Skipper and Skipper Race Guidewire | Invatec Innovative Technologies, S.R.L. | 2005 | — |
| −1 | K060551 | Brivant Guidewire | Brivant Limited | 2006 | — |
| 0 (this device) | K160643 | ENROUTE 0.014 Guidewire | Lake Region Medical | 2016 | — |
| +1 | 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 |
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? (2)
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 |
|---|---|---|---|
| * | K060551 | Brivant GuidewireSummary page 5…al 510(k) Predicate Device Manufacturer 510k Date Brivant Guidewire (Rapidwire Plus variant – K060551 06/07/2006 previously known as SLK) Nitrex Nitinol Guidewire… | 2006 |
| * | K040345 | Modification to Nitrex Nitinol GuidewireSummary page 5…re (Rapidwire Plus variant – K060551 06/07/2006 previously known as SLK) Nitrex Nitinol Guidewire K040345 03/02/2004 Principle of The ENROUTE 0.014” guidewire is operated manually by a manual process Operation Comparison… | 2004 |
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 |
|---|---|---|---|
| K253746 | Enroute 0.014'' Transcarotid Guidewire | 2026 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K253746 (Lake Region Medical, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K060551.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 0.014" Guidewire is intended for use in the peripheral vasculature.
Contraindications:
ENROUTE 0.014" Guidewire is not intended for use in:
- The cerebral or coronary vasculature
- Patients judged not acceptable for percutaneous intervention
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K160643: ENROUTE 0.014 Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K160643
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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